Trial Outcomes & Findings for A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing (NCT NCT01039467)

NCT ID: NCT01039467

Last Updated: 2020-02-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 385 participants
• Primary outcome timeframe: 1 month post-implantation
• Results posted on: 2020-02-05

Participant Flow

Enrollment period: 18 JUN 2009 to 15 MAR 2010.

6 patients withdrawn from study pre-randomization for not meeting inclusion/exclusion criteria.

Participant milestones

Measure	Managed Ventricular Pacing (MVP) Managed Ventricular Pacing (MVP) used in dual chamber pacemaker	Search AV+ Search AV+ used in dual chamber pacemaker
Overall Study STARTED	196	189
Overall Study COMPLETED	156	140
Overall Study NOT COMPLETED	40	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing

Baseline characteristics by cohort

Measure	Managed Ventricular Pacing (MVP) n=196 Participants Managed Ventricular Pacing (MVP) used in dual chamber pacemaker	Search AV+ n=189 Participants Search AV+ used in dual chamber pacemaker	Total n=385 Participants Total of all reporting groups
Age, Continuous	69.87 years STANDARD_DEVIATION 10.35 • n=5 Participants	70.71 years STANDARD_DEVIATION 9.89 • n=7 Participants	70.28 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	81 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	108 Participants n=7 Participants	211 Participants n=5 Participants
Region of Enrollment China	196 participants n=5 Participants	189 participants n=7 Participants	385 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=167 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=163 Participants Search AV+ (SAV+)
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: all participants who completed the 12 months visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=156 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=140 Participants Search AV+ (SAV+)
Percent of Ventricular Pacing	0.40 percent of ventricular pacing (%VP) Standard Deviation 31.46	2.95 percent of ventricular pacing (%VP) Standard Deviation 40.05

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %AT/AF burden data available.

To compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients by measuring the percent burden of atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.

Outcome measures

Measure	Managed Ventricular Pacing n=37 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=35 Participants Search AV+ (SAV+)
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant	1.40 Percentage of decreasedAT/AF burden Standard Deviation 20.27	0.50 Percentage of decreasedAT/AF burden Standard Deviation 25.43

SECONDARY outcome

Timeframe: from 1 month to 12 months post-implantation

Population: all participants who completed the 12 months visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=141 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=129 Participants Search AV+ (SAV+)
Change in Percent of Ventricular Pacing	-0.10 percent of ventricular pacing (%VP) Standard Deviation 20.20	0.00 percent of ventricular pacing (%VP) Standard Deviation 20.18

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 12 months visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=167 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=163 Participants Search AV+ (SAV+)
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)	132 Participants	91 Participants

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=105 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=110 Participants Search AV+ (SAV+)
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=18 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=10 Participants Search AV+ (SAV+)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)	1.50 percent of ventricular pacing (%VP) Standard Deviation 23.65	21.80 percent of ventricular pacing (%VP) Standard Deviation 41.00

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=31 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=33 Participants Search AV+ (SAV+)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)	21.40 percent of ventricular pacing (%VP) Standard Deviation 39.16	80.60 percent of ventricular pacing (%VP) Standard Deviation 44.03

SECONDARY outcome

Timeframe: 1 month post-implantation

Population: all participants who completed the 1 month visit with %VP data available.

Outcome measures

Measure	Managed Ventricular Pacing n=13 Participants Managed Ventricular Pacing (MVP)	Search AV+ n=10 Participants Search AV+ (SAV+)
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)	79.20 percent of ventricular pacing (%VP) Standard Deviation 44.68	22.45 percent of ventricular pacing (%VP) Standard Deviation 47.13

Adverse Events

Managed Ventricular Pacing

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Search AV+

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Managed Ventricular Pacing n=196 participants at risk Managed Ventricular Pacing (MVP)	Search AV+ n=189 participants at risk Search AV+ (SAV+)
General disorders Death (unknown reason)	0.51% 1/196 • Number of events 1 • 12 months	0.53% 1/189 • Number of events 1 • 12 months
General disorders Sudden cardiac death (CHD)	0.00% 0/196 • 12 months	1.1% 2/189 • Number of events 2 • 12 months
General disorders Non-cardiac death (cancer)	0.00% 0/196 • 12 months	1.1% 2/189 • Number of events 2 • 12 months
General disorders Non-cardiac death (cerebrovascular accident）	0.00% 0/196 • 12 months	0.53% 1/189 • Number of events 1 • 12 months
Infections and infestations Pocket infection	0.51% 1/196 • Number of events 1 • 12 months	0.00% 0/189 • 12 months
Surgical and medical procedures Dislodgement of RV lead and reposition of the lead	0.00% 0/196 • 12 months	0.53% 1/189 • Number of events 1 • 12 months

Other adverse events

Measure	Managed Ventricular Pacing n=196 participants at risk Managed Ventricular Pacing (MVP)	Search AV+ n=189 participants at risk Search AV+ (SAV+)
Nervous system disorders dizziness	1.0% 2/196 • 12 months	1.6% 3/189 • 12 months

Additional Information

Dr. Shu Zhang

Fuwai Hospital

Phone: 861088398833

Email: zsfuwai@vip.163.com

Results disclosure agreements

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