Bradycardia
Conditions
Keywords
Managed Ventricular Pacing
Brief summary
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.
Detailed description
Recent studies suggest that chronic right ventricular pacing is associated with a variety of adverse effects in patients, particularly those with intact or intermittent atrioventricular (AV) conduction. Medtronic Adapta® pacemakers include Managed Ventricular Pacing®, a pacing mode designed to promote intrinsic conduction, and also Search AV™+, a feature designed to reduce unnecessary ventricular pacing in patients with intact or intermittent AV conduction.
Interventions
DEVICEMedtronic Adapta Dual Chamber Pacemaker
Medtronic Adapta Dual Chamber Pacemaker
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated study informed consent * Class I or Class IIa pacemaker indication * Geographically stable and available for follow-up at the center for the length of the study * Age greater than 18 * To be implanted with Adapta dual chamber pacemaker
Exclusion criteria
* Unwillingness or inability to give written informed consent to participate in the Study * Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device * Life expectancy of less than one year * Patient has a mechanical tricuspid heart valve * Medical conditions that preclude the testing requirement by the protocol or limit study participation * Patient has persistent 3rd degree atrioventricular (AV) block * Patient has persistent atrial fibrillation (AF) * Patient has neurogenic syncope * Patient has carotid sinus syndrome * Patient has hypertrophic obstructive cardiomyopathy * Inclusion in another clinical trial or study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ | 1 month post-implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant | 1 month post-implantation | 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. |
| Change in Percent of Ventricular Pacing | from 1 month to 12 months post-implantation | — |
| Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP) | 1 month post-implantation | — |
| Percent of Ventricular Pacing | 12 months post-implantation | — |
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB) | 1 month post-implantation | — |
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB) | 1 month post-implantation | — |
| Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB) | 1 month post-implantation | — |
| Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB) | 1 month post-implantation | — |
Countries
China
Participant flow
Recruitment details
Enrollment period: 18 JUN 2009 to 15 MAR 2010.
Pre-assignment details
6 patients withdrawn from study pre-randomization for not meeting inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Managed Ventricular Pacing (MVP) Managed Ventricular Pacing (MVP) used in dual chamber pacemaker | 196 |
| Search AV+ Search AV+ used in dual chamber pacemaker | 189 |
| Total | 385 |
Baseline characteristics
| Characteristic | Managed Ventricular Pacing (MVP) | Search AV+ | Total |
|---|---|---|---|
| Age, Continuous | 69.87 years STANDARD_DEVIATION 10.35 | 70.71 years STANDARD_DEVIATION 9.89 | 70.28 years STANDARD_DEVIATION 10.12 |
| Region of Enrollment China | 196 participants | 189 participants | 385 participants |
| Sex: Female, Male Female | 93 Participants | 81 Participants | 174 Participants |
| Sex: Female, Male Male | 103 Participants | 108 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 196 | 3 / 189 |
| serious Total, serious adverse events | 2 / 196 | 7 / 189 |
Outcome results
Primary
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with %VP data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Managed Ventricular Pacing | Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ | 1 Participants |
| Search AV+ | Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ | 4 Participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change in Percent of Ventricular Pacing
Time frame: from 1 month to 12 months post-implantation
Population: all participants who completed the 12 months visit with %VP data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | Change in Percent of Ventricular Pacing | -0.10 percent of ventricular pacing (%VP) | Standard Deviation 20.2 |
| Search AV+ | Change in Percent of Ventricular Pacing | 0.00 percent of ventricular pacing (%VP) | Standard Deviation 20.18 |
p-value: 0.265Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with %VP data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Managed Ventricular Pacing | Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB) | 1 Participants |
| Search AV+ | Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB) | 1 Participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
Time frame: 1 month post-implantation
Population: all participants who completed the 12 months visit with %VP data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Managed Ventricular Pacing | Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP) | 132 Participants |
| Search AV+ | Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP) | 91 Participants |
p-value: <0.0001Chi-squared
Secondary
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant
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.
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with~%AT/AF burden data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant | 1.40 Percentage of decreasedAT/AF burden | Standard Deviation 20.27 |
| Search AV+ | Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant | 0.50 Percentage of decreasedAT/AF burden | Standard Deviation 25.43 |
p-value: 0.833Wilcoxon (Mann-Whitney)
Secondary
Percent of Ventricular Pacing
Time frame: 12 months post-implantation
Population: all participants who completed the 12 months visit with %VP data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | Percent of Ventricular Pacing | 0.40 percent of ventricular pacing (%VP) | Standard Deviation 31.46 |
| Search AV+ | Percent of Ventricular Pacing | 2.95 percent of ventricular pacing (%VP) | Standard Deviation 40.05 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with %VP data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB) | 1.50 percent of ventricular pacing (%VP) | Standard Deviation 23.65 |
| Search AV+ | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB) | 21.80 percent of ventricular pacing (%VP) | Standard Deviation 41 |
p-value: 0.0008Wilcoxon (Mann-Whitney)
Secondary
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with %VP data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | 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 |
| Search AV+ | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB) | 80.60 percent of ventricular pacing (%VP) | Standard Deviation 44.03 |
p-value: 0.053Wilcoxon (Mann-Whitney)
Secondary
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)
Time frame: 1 month post-implantation
Population: all participants who completed the 1 month visit with %VP data available.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Managed Ventricular Pacing | 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 |
| Search AV+ | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB) | 22.45 percent of ventricular pacing (%VP) | Standard Deviation 47.13 |
p-value: 0.493Wilcoxon (Mann-Whitney)