Trial Outcomes & Findings for Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study (NCT NCT02548455)

Last Updated: 2019-02-04

Results Overview

A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.

Recruitment status

COMPLETED

Study phase

Target enrollment

499 participants

Primary outcome timeframe

3 months

Results posted on

2019-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead
Overall Study STARTED	499
Overall Study Completed Pre-Discharge	484
Overall Study Completed 6-Month Follow-up	259
Overall Study Completed 12-Month Follow-up	61
Overall Study COMPLETED	259
Overall Study NOT COMPLETED	240

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead
Overall Study Withdrawal by Subject	27
Overall Study Death	26
Overall Study Lost to Follow-up	14
Overall Study Visit not completed	173

Baseline Characteristics

Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=499 Participants Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead
Age, Continuous	72.3 years STANDARD_DEVIATION 10.4 • n=99 Participants
Sex: Female, Male Female	194 Participants n=99 Participants
Sex: Female, Male Male	305 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	491 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	39 Participants n=99 Participants
Race (NIH/OMB) White	450 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants
Region of Enrollment United States	499 Participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The first 94 subjects who underwent an attempted implant of the Quartet 1457Q lead and either completed a 3-month follow-up visit, withdrew from the study or died prior to the 3-month follow-up visit.

Outcome measures

Outcome measures
Measure	Treatment n=94 Participants Subjects implanted with the Quartet 1457Q left ventricular lead
Number of Patients Free From LV Lead-related Complications Through 3 Months	4 Participants

Adverse Events

Treatment

Serious events: 60 serious events

Other events: 56 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=499 participants at risk Subjects implanted with the Quartet 1457Q left ventricular lead
Injury, poisoning and procedural complications Cardiac Tamponade	0.60% 3/499 • Number of events 3 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Coronary Sinus Dissection	0.80% 4/499 • Number of events 4 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Coronary Sinus Perforation	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Excessive Bleeding	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Hematoma/Seroma	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Induced Arrhythmias Atrial/Ventricular	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Infections	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Infections and infestations Infections	1.0% 5/499 • Number of events 5 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Lead Dislodgement	4.0% 20/499 • Number of events 20 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Lead Dislodgement	2.8% 14/499 • Number of events 14 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Loss of Pacing/Sensing	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Pectoral/Diaphragmatic Stimulation	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Pericardial Effusion	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Pneumothorax	1.2% 6/499 • Number of events 6 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Pulmonary Edema	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Rise in Threshold	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Rise in Threshold	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Anesthesia Complication	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Cardiogenic Shock	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Elevated Pacing Threshold	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Guide Wire Problem	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Hypotension	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Loose Set Screw	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory Compromise	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Upper Extremity Deep Vein Thrombosis	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.

Other adverse events

Other adverse events
Measure	Treatment n=499 participants at risk Subjects implanted with the Quartet 1457Q left ventricular lead
Injury, poisoning and procedural complications Cardiac/Coronary Sinus Dissection	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Cardiac/Coronary Sinus Perforation	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Hematoma/Seroma	1.4% 7/499 • Number of events 7 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Induced Atrial or Ventricular Arrythmias	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Infection	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Lead Dislodgement	1.0% 5/499 • Number of events 6 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Lead Dislodgement	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Skin and subcutaneous tissue disorders Local Tissue Reaction; Formation of Fibrotic Tissue	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Pectoral/Diaphramatic/Phrenic Nerve Stimulation	4.0% 20/499 • Number of events 22 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Pectoral/Diaphramatic/Phrenic Nerve Stimulation	2.0% 10/499 • Number of events 10 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
General disorders Oversensing	0.40% 2/499 • Number of events 2 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Upper Extremity Discomfort	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Oversensing	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Should Pain	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Suture Sleeve Disruption	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Injury, poisoning and procedural complications Upper Extremity Deep Vein Thrombosis	0.60% 3/499 • Number of events 3 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Device Reset Mode	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Elevated Threshold	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Product Issues Oversensing	0.20% 1/499 • Number of events 1 • Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.

Additional Information

Clay Cohorn, Clinical Program Director

Abbott

Phone: 972-309-8087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60