Trial Outcomes & Findings for NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial (NCT NCT05666713)

Last Updated: 2026-02-03

Results Overview

The primary efficacy endpoint is technical success, which is defined when the following criteria are all met: 1. Successful electrosurgical leaflet traversal using the TELLTALE Guidewire 2. Successful electrosurgical leaflet laceration using the TELLTALE Guidewire 3. Successful retrieval of the TELLTALE Guidewire System

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

1 minute following procedure discharge (Exit from the catheterization laboratory)

Results posted on

2026-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system. TELLTALE BASILICA procedure: The TELLTALE BASILICA procedure has five steps: (1) engagement of the target leaflet with a guiding catheter; (2) electrosurgical leaflet traversal with the TELLTALE guidewire, (3) preparation and positioning of the TELLTALE guidewire electrosurgical leaflet laceration surface; (4) electrosurgical leaflet laceration with the TELLTALE guidewire, immediately followed by (5) TAVR. These are all guided by fluoroscopy, with adjunctive echocardiography as needed.
Overall Study STARTED	90
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system. TELLTALE BASILICA procedure: The TELLTALE BASILICA procedure has five steps: (1) engagement of the target leaflet with a guiding catheter; (2) electrosurgical leaflet traversal with the TELLTALE guidewire, (3) preparation and positioning of the TELLTALE guidewire electrosurgical leaflet laceration surface; (4) electrosurgical leaflet laceration with the TELLTALE guidewire, immediately followed by (5) TAVR. These are all guided by fluoroscopy, with adjunctive echocardiography as needed.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 Participants Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system. TELLTALE BASILICA procedure: The TELLTALE BASILICA procedure has five steps: (1) engagement of the target leaflet with a guiding catheter; (2) electrosurgical leaflet traversal with the TELLTALE guidewire, (3) preparation and positioning of the TELLTALE guidewire electrosurgical leaflet laceration surface; (4) electrosurgical leaflet laceration with the TELLTALE guidewire, immediately followed by (5) TAVR. These are all guided by fluoroscopy, with adjunctive echocardiography as needed.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=41 Participants
Age, Categorical >=65 years	85 Participants n=41 Participants
Sex: Female, Male Female	59 Participants n=41 Participants
Sex: Female, Male Male	31 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	1 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	2 Participants n=41 Participants
Race (NIH/OMB) White	82 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=41 Participants
Region of Enrollment United States	90 Participants n=41 Participants

PRIMARY outcome

Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)

Outcome measures

Outcome measures
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 Participants Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System	90 Participants

PRIMARY outcome

Timeframe: Upon discharge from the index hospital admission, up to 30 days

Inpatient safety as defined by: 1. Freedom from all-cause mortality as defined as the total number of deaths from any cause 2. Freedom from stroke, both disabling and non-disabling * Disabling stroke according to VARC-3 is defined as a stroke resulting in significant, persistent neurological deficits that impact a patient's ability to perform daily activities. * Non-disabling stroke according to VARC-3, involves stroke symptoms that don't significantly impair a patient's ability to perform daily activities or lead to a worsening of their pre-stroke disability level. 3. Freedom from acute coronary artery obstruction 4. Freedom from emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device- 5. Freedom from BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet

Outcome measures

Outcome measures
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 Participants Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
Number of Inpatient Safety Events All-cause Mortality	0 Safety Events
Number of Inpatient Safety Events Stroke, disabling	1 Safety Events
Number of Inpatient Safety Events Stroke, non-disabling	2 Safety Events
Number of Inpatient Safety Events Coronary obstruction	1 Safety Events
Number of Inpatient Safety Events Emergency cardiac surgery or reintervention	0 Safety Events
Number of Inpatient Safety Events BASILICA related complications	0 Safety Events

SECONDARY outcome

Timeframe: Up to Day 30

30-day safety as assessed by freedom from * Major Adverse Cardiovascular Events defined by no periprocedural myocardial infarction, cerebrovascular events, and periprocedural all-cause mortality * All-cause mortality: defined as total number of deaths from any cause * All stroke (disabling and non-disabling per VARC-3) * Disabling results in significant, persistent neurological deficits that impact daily activities * Non-disabling involves stroke symptoms that don't significantly impair daily activities or lead to worsening of their pre-stroke level * Bleeding VARC-3 Type 2 or greater requiring two or more units of transfused blood or hemoglobin drop \>3g/dL * Major vascular, access-related, or cardiac structural complication according to VARC-3, including coronary obstruction * Acute kidney injury stage 3 or 4 * Moderate or severe aortic regurgitation * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the TELLTALE device

Outcome measures

Outcome measures
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 Participants Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
Freedom From Safety Events	89 percentage of participants Interval 80.0 to 94.0

Adverse Events

Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System

Serious events: 36 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 participants at risk Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
Blood and lymphatic system disorders Anemia	8.9% 8/90 • Number of events 8 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Blood and lymphatic system disorders Heparin Induced Thrombocytopenia (HIT)	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Arterial injury	5.6% 5/90 • Number of events 5 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Lung infection	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Sepsis	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Fall	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Bronchial Infection	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Acute coronary obstruction post TAVR	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Injury to jugular vein	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Wound dehiscence	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Arterial thromboembolism	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Hypertension	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Hypotension	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Thromboembolic event	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Atrial fibrillation	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Atrioventricular block complete	5.6% 5/90 • Number of events 5 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Conduction disorder	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Heart failure	3.3% 3/90 • Number of events 6 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Sick sinus syndrome	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Ventricular tachycardia	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations Creatinine increased	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Psychiatric disorders Delirium	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Endocarditis infective	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Skin infection	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Upper respiratory infection	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Renal and urinary disorders Hematuria	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Renal and urinary disorders Urinary retention	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Metabolism and nutrition disorders Hyperkalemia	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Metabolism and nutrition disorders Hypoglycemia	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Reoccurrence of Mantle Cell Lymphoma	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Eye disorders Retinal detachment	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Stroke	6.7% 6/90 • Number of events 7 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Surgical and medical procedures Total right hip arthroplasty	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.

Other adverse events

Other adverse events
Measure	Participants Undergoing TAVR With BASILICA Using Transmural TELLTALE Guidewire System n=90 participants at risk Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
Gastrointestinal disorders Abdominal pain	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Gastrointestinal disorders Constipation	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Gastrointestinal disorders Gastroesophageal reflux disease	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Gastrointestinal disorders Vomiting	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations Creatinine increased	8.9% 8/90 • Number of events 9 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations Cardiac troponin I increased	21.1% 19/90 • Number of events 19 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations Ejection fraction decreased	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations TELLTALE guidewire Non-target traversal	6.7% 6/90 • Number of events 6 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Investigations Platelet count decreased	10.0% 9/90 • Number of events 9 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Blood and lymphatic system disorders Anemia	16.7% 15/90 • Number of events 15 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Blood and lymphatic system disorders Hematocrit decreased post procedure	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Blood and lymphatic system disorders B-cell lymphoma	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Blood and lymphatic system disorders Leukocytosis	8.9% 8/90 • Number of events 8 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Arterial injury	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Arterial thromboembolism	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Bruising	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Fall	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Coccyx pain	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Injury, poisoning and procedural complications Minor Groin bleed	12.2% 11/90 • Number of events 11 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Atrial fibrillation	6.7% 6/90 • Number of events 6 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Cardiac troponin I increased	21.1% 19/90 • Number of events 19 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Chest pain - cardiac	5.6% 5/90 • Number of events 5 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Conduction disorder	17.8% 16/90 • Number of events 17 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Left ventricular systolic dysfunction	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Palpitations	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
General disorders Chills	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
General disorders Edema limbs	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
General disorders Fatigue	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
General disorders Fever	3.3% 3/90 • Number of events 3 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
General disorders Non-cardiac chest pain	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Dizziness	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Headache	2.2% 2/90 • Number of events 2 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Memory impairment	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Syncope	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Nervous system disorders Trigeminal nerve disorder	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Hematoma	3.3% 3/90 • Number of events 3 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Hypertension	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Vascular disorders Hypotension	6.7% 6/90 • Number of events 6 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Skin and subcutaneous tissue disorders Rash acneiform	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Scrotal infection	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Infections and infestations Urinary tract infection	4.4% 4/90 • Number of events 4 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Renal and urinary disorders Urinary retention	3.3% 3/90 • Number of events 3 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.
Cardiac disorders Mobitz (type) II atrioventricular block	1.1% 1/90 • Number of events 1 • Up to 90 Days All adverse events (AE) and adverse device effects (ADE) through the 30 days follow-up will be reported. All serious adverse device effects (SADE), serious adverse events (SAE), unanticipated device effects (UADE), and unanticipated problems (UP) will be recorded through the 90 days follow up.

Additional Information

Robert Lederman, M.D.

National Heart Lung and Blood Institute

Phone: 301.402.6769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place