Trial Outcomes & Findings for Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study (NCT NCT00990665)

NCT ID: NCT00990665

Last Updated: 2019-02-27

Results Overview

The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 178 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-02-27

Participant Flow

Participant milestones

Measure	CRT-D and LV Lead CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Overall Study STARTED	178
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Measure	CRT-D and LV Lead CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Overall Study Unsuccessful Implant	8
Overall Study Death	29
Overall Study Heart Transplant	1
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	1
Overall Study System Explant	3

Baseline Characteristics

Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

Baseline characteristics by cohort

Measure	CRT-D and LV Lead n=178 Participants CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Age, Continuous	68 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
New York Heart Association Class Class III	175 participants n=5 Participants
New York Heart Association Class Class IV	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Patients implanted with a Promote Q CRT-D device and Quartet LV lead.

The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.

Outcome measures

Measure	CRT-D and LV Lead n=178 Participants CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead	Patients Per Complete Case Analysis Complete case analysis includes only the number of patients that were successfully implanted with the Promote Q CRT-D and Quartet LV lead.
Freedom From Left Ventricular Lead-Related Complications Through 3 Months	96 percentage probability Interval 93.0 to Upper bound was not calculated for this outcome measure with one sided hypothesis	—

PRIMARY outcome

Timeframe: 3 Months

Population: Participants implanted with a Promote Q CRT-D device and Quartet LV lead.

The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.

Outcome measures

Measure	CRT-D and LV Lead n=178 Participants CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead	Patients Per Complete Case Analysis Complete case analysis includes only the number of patients that were successfully implanted with the Promote Q CRT-D and Quartet LV lead.
Freedom From System-related Complications Through 3 Months	92 percentage probability Interval 88.0 to Upper bound was not calculated for this outcome measure with one sided hypothesis	—

PRIMARY outcome

Timeframe: 3 Months

The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).

Outcome measures

Measure	CRT-D and LV Lead n=178 Participants CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead	Patients Per Complete Case Analysis n=162 Participants Complete case analysis includes only the number of patients that were successfully implanted with the Promote Q CRT-D and Quartet LV lead.
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.	79.2 percentage of participants Interval 72.5 to Upper bound was not calculated for this outcome measure with one sided hypothesis	83.3 percentage of participants Interval 76.7 to Upper bound was not calculated for this outcome measure with one sided hypothesis

Adverse Events

CRT-D and LV Lead

Serious events: 0 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CRT-D and LV Lead n=178 participants at risk CRT-D and LV Lead
Cardiac disorders Complications	15.7% 28/178 • Number of events 36
Cardiac disorders Observations	27.0% 48/178 • Number of events 59

Additional Information

Clay Cohorn: Director, Clinical Study Management

St. Jude Medical

Phone: 972 309 8087

Email: ccohorn@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place