Trial Outcomes & Findings for Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip (NCT NCT04729933)
NCT ID: NCT04729933
Last Updated: 2026-08-05
Results Overview
Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Up to1 month post implant
Results posted on
2026-08-05
Participant Flow
Participant milestones
| Measure |
Treatment
V-Wave Shunt Placement
V-Wave Shunt Placement: After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
Baseline characteristics by cohort
| Measure |
Treatment
n=10 Participants
V-Wave Shunt Placement
V-Wave Shunt Placement: After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Chronic Kidney Disease
Yes
|
6 Participants
n=20 Participants
|
|
Chronic Kidney Disease
No
|
4 Participants
n=20 Participants
|
|
Coronary Artery Disease
Yes
|
9 Participants
n=20 Participants
|
|
Coronary Artery Disease
No
|
1 Participants
n=20 Participants
|
|
Diabetes
Yes
|
5 Participants
n=20 Participants
|
|
Diabetes
No
|
5 Participants
n=20 Participants
|
|
Hyperlipidemia
Yes
|
9 Participants
n=20 Participants
|
|
Hyperlipidemia
No
|
1 Participants
n=20 Participants
|
|
Hypertension
Yes
|
8 Participants
n=20 Participants
|
|
Hypertension
No
|
2 Participants
n=20 Participants
|
|
Myocardial Infarction
Yes
|
8 Participants
n=20 Participants
|
|
Myocardial Infarction
No
|
2 Participants
n=20 Participants
|
|
Peripheral Artery Disease
Yes
|
2 Participants
n=20 Participants
|
|
Peripheral Artery Disease
No
|
8 Participants
n=20 Participants
|
|
Pulmonary Disease
Yes
|
5 Participants
n=20 Participants
|
|
Pulmonary Disease
No
|
5 Participants
n=20 Participants
|
|
Smoking Status
Current Smoker
|
2 Participants
n=20 Participants
|
|
Smoking Status
Former Smoker
|
6 Participants
n=20 Participants
|
|
Smoking Status
Never Smoked
|
2 Participants
n=20 Participants
|
|
Arrhythmia Disorders
Yes
|
8 Participants
n=20 Participants
|
|
Arrhythmia Disorders
No
|
2 Participants
n=20 Participants
|
|
Stroke
Yes
|
0 Participants
n=20 Participants
|
|
Stroke
No
|
10 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to1 month post implantNumber occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery
Outcome measures
| Measure |
Treatment
n=10 Participants
V-Wave Shunt Placement
V-Wave Shunt Placement: After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
|
|---|---|
|
Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE)
|
3 events
|
Adverse Events
Treatment
Serious events: 9 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment
n=10 participants at risk
V-Wave Shunt Placement
V-Wave Shunt Placement: After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
|
|---|---|
|
Cardiac disorders
Congestive Heart Failure
|
20.0%
2/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • Up to 5 years
|
|
Renal and urinary disorders
End Stage Renal Disease
|
20.0%
2/10 • Up to 5 years
|
|
Infections and infestations
Flu
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Heart Failure
|
30.0%
3/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
20.0%
2/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD Excacerbation
|
20.0%
2/10 • Up to 5 years
|
|
Investigations
Hypokalemia
|
10.0%
1/10 • Up to 5 years
|
|
Infections and infestations
Toe Infection
|
10.0%
1/10 • Up to 5 years
|
|
Gastrointestinal disorders
Nausia
|
10.0%
1/10 • Up to 5 years
|
|
Vascular disorders
Peripheral Vascular Disease
|
10.0%
1/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
1/10 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • Up to 5 years
|
|
Cardiac disorders
Syncope
|
10.0%
1/10 • Up to 5 years
|
|
Vascular disorders
Thrombosis
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Tricuspid Regurgitation
|
10.0%
1/10 • Up to 5 years
|
|
Infections and infestations
Viral Upper Respiratory Infection
|
10.0%
1/10 • Up to 5 years
|
|
Blood and lymphatic system disorders
Acute Blood Loss Anemia
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Acute Decompensated Heart Failure
|
20.0%
2/10 • Up to 5 years
|
|
Nervous system disorders
Acute Intercreneal Hemorrhage
|
10.0%
1/10 • Up to 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Acute on Chronic Systolic and Diastolic Heart Failure
|
40.0%
4/10 • Up to 5 years
|
|
Infections and infestations
Bacteremia
|
10.0%
1/10 • Up to 5 years
|
|
Renal and urinary disorders
Cardio Renal Syndrome
|
10.0%
1/10 • Up to 5 years
|
Other adverse events
| Measure |
Treatment
n=10 participants at risk
V-Wave Shunt Placement
V-Wave Shunt Placement: After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
30.0%
3/10 • Up to 5 years
|
|
Infections and infestations
Shock
|
10.0%
1/10 • Up to 5 years
|
|
Blood and lymphatic system disorders
Cancer
|
10.0%
1/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Cough
|
10.0%
1/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Increase in Size in Pulmonary Nodules
|
10.0%
1/10 • Up to 5 years
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
1/10 • Up to 5 years
|
|
Infections and infestations
Osteomyelitis
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Persistent Atrial Fibrillation
|
10.0%
1/10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
1/10 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Bilateral Leg Wounds
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Atrial Septal Defect
|
10.0%
1/10 • Up to 5 years
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
10.0%
1/10 • Up to 5 years
|
|
Investigations
Hyperkalemia
|
10.0%
1/10 • Up to 5 years
|
|
Infections and infestations
Covid-19
|
20.0%
2/10 • Up to 5 years
|
|
Cardiac disorders
Worsening Mitral Regurgitation
|
20.0%
2/10 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place