Trial Outcomes & Findings for Dual Site Left Ventricular (LV) Pacing (NCT NCT00944125)

Last Updated: 2024-10-21

Results Overview

The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.

Recruitment status

TERMINATED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

At 6 months to one year

Results posted on

2024-10-21

Participant Flow

Subjects are consented and randomized before the pacing prodecure. They may have been excluded (considered screen fails) if they end up not having the procedure or being identified as inappropriate once the procedure began. 50 Consented and 41 Randomized.

Participant milestones

Participant milestones
Measure	Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months.	BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study.
Baseline to 3 Months STARTED	19	22
Baseline to 3 Months COMPLETED	19	22
Baseline to 3 Months NOT COMPLETED	0	0
3 to 6 Months STARTED	19	22
3 to 6 Months COMPLETED	19	20
3 to 6 Months NOT COMPLETED	0	2
6 Months to Study Completion STARTED	19	20
6 Months to Study Completion COMPLETED	19	18
6 Months to Study Completion NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months.	BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study.
3 to 6 Months Withdrawal by Subject	0	2
6 Months to Study Completion Withdrawal by Subject	0	2

Baseline Characteristics

Dual Site Left Ventricular (LV) Pacing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=50 Participants Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study.
Age, Continuous	69.5 years STANDARD_DEVIATION 10.98 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months to one year

Population: Analysis population was based on the two randomized groups per the protocol.

Outcome measures

Outcome measures
Measure	Dual Site LV Pacing n=17 Participants	BiV Pacing n=14 Participants
Change in Left Ventricular End Systolic Volume (LVESV)	-28.16 ml Standard Deviation 14.62	-25.91 ml Standard Deviation 27.84

Adverse Events

Dual Site LV Pacing

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

BiV Pacing

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dual Site LV Pacing n=41 participants at risk Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months.	BiV Pacing n=41 participants at risk Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study.
General disorders Diaphragmatic Stimulation	17.1% 7/41 • Number of events 7 • 1 year Adverse Events were collected per intervention.	7.3% 3/41 • Number of events 3 • 1 year Adverse Events were collected per intervention.
General disorders Fatigue	7.3% 3/41 • Number of events 3 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.

Additional Information

Imran K. Niazi, MD

Aurora Health Care

Phone: 414-645-6070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dual Site LV Pacing n=41 participants at risk Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months.	BiV Pacing n=41 participants at risk Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study.
Vascular disorders Syncope	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Cardiac disorders Heart failure	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
General disorders Death	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
General disorders Multi-organ failure	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
Blood and lymphatic system disorders Sepsis	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
General disorders Fall	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were collected per intervention.
Cardiac disorders Chest pain - cardiac	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	4.9% 2/41 • Number of events 2 • 1 year Adverse Events were collected per intervention.
Renal and urinary disorders Hyperkalemia	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Gastrointestinal disorders Vomiting	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
Gastrointestinal disorders Stomach pain	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Gastrointestinal disorders Rectal fistula	0.00% 0/41 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Cardiac disorders ICD shock	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.
Cardiac disorders Lead dislodgement	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.
Blood and lymphatic system disorders Anemia	2.4% 1/41 • Number of events 1 • 1 year Adverse Events were collected per intervention.	0.00% 0/41 • 1 year Adverse Events were collected per intervention.