Trial Outcomes & Findings for Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (NCT NCT01278030)

NCT ID: NCT01278030

Last Updated: 2019-02-19

Results Overview

The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: At 6 month follow-up
• Results posted on: 2019-02-19

Participant Flow

Participant milestones

Measure	3D Echo-guided LV Lead Placement The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.	Control Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
Overall Study STARTED	43	35
Overall Study COMPLETED	35	31
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Measure	3D Echo-guided LV Lead Placement The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.	Control Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
Overall Study Withdrawal by Subject	8	4

Baseline Characteristics

Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates

Baseline characteristics by cohort

Measure	3D Echo-guided LV Lead Placement n=43 Participants The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.	Control n=35 Participants Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 13 • n=5 Participants	67 years STANDARD_DEVIATION 11 • n=7 Participants	67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	35 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 month follow-up

Population: Patients who completed the 6 month follow-up with implant 3D echo data.

The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.

Outcome measures

Measure	3D Echo-guided LV Lead Placement n=33 Participants The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.	Control n=25 Participants Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
Responder Rate	67 percentage of participants	60 percentage of participants

Adverse Events

3D Echo-guided LV Lead Placement

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	3D Echo-guided LV Lead Placement n=43 participants at risk The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.	Control n=35 participants at risk Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
Infections and infestations Infection	0.00% 0/43 • 6 months	2.9% 1/35 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Pericardial Effusion	2.3% 1/43 • Number of events 1 • 6 months	0.00% 0/35 • 6 months

Additional Information

John Gill

St. Jude Medical

Phone: 818-493-2609

Email: jgill@sjm.com

Results disclosure agreements

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