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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Managed Ventricular Pacing | Active Comparator | Managed Ventricular Pacing group: programmed on |
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| Search AV+ | Active Comparator | Search AV+: programmed on |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Adapta Dual Chamber Pacemaker | Device | Medtronic Adapta Dual Chamber Pacemaker |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ | 1 month post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Ventricular Pacing | 12 months post-implantation | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu Zhang, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3rd Hospital of Beijing University | Beijing | Beijing Municipality | China | |||
| Anzhen Hospital |
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6 patients withdrawn from study pre-randomization for not meeting inclusion/exclusion criteria.
Enrollment period: 18 JUN 2009 to 15 MAR 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Managed Ventricular Pacing (MVP) | Managed Ventricular Pacing (MVP) used in dual chamber pacemaker |
| FG001 | Search AV+ | Search AV+ used in dual chamber pacemaker |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 month post-implantation |
| 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 |
| Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB) | 1 month 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 |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | China |
| Fuwai Hospital | Beijing | Beijing Municipality | China |
| Fujian Province Hospital | Fuzhou | Fujian | China |
| 1st Hospital of Zhongshan Medical University | Guangzhou | Guangdong | China |
| 2nd Hospital of Zhongshan Medical University | Guangzhou | Guangdong | China |
| Guangdong Province People's Hospital | Guangzhou | Guangdong | China |
| 1st Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Wuhan Asian Heart Hospital | Wuhan | Hubei | China |
| Wuhan Union Hospital | Wuhan | Hubei | China |
| Xiangya Second Hospital, Central South University | Changsha | Hunan | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| 2nd Hospital of Jilin University | Changchun | Jilin | China |
| Liaoning Province People's Hospital | Shenyang | Liaoning | China |
| Affiliated Hospital of Qingdao Medical College | Qingdao | Shandong | China |
| Shanghai Huadong Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Minhang District Hospital | Shanghai | Shanghai Municipality | China |
| General Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | China |
| First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| Xinjiang Automatic District Hospital | Ürümqi | Xinjiang | China |
| 1st Hospital of Kunming Medical College | Kunming | Yunnan | China |
| Yunnan Province 1st People's Hospital | Kunming | Yunnan | China |
| Yuxi People's Hospital | Yuxi | Yunnan | China |
| 1st Hospital of Medical College, Zhejiang University | Hangzhou | Zhejiang | China |
| 2nd Hospital of Medical College, Zhejiang University | Hangzhou | Zhejiang | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | China |
| Shanghai First People's Hospital | Shanghai | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Managed Ventricular Pacing (MVP) | Managed Ventricular Pacing (MVP) used in dual chamber pacemaker |
| BG001 | Search AV+ | Search AV+ used in dual chamber pacemaker |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ | all participants who completed the 1 month visit with %VP data available. | Posted | Count of Participants | Participants | 1 month post-implantation |
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| Secondary | Percent of Ventricular Pacing | all participants who completed the 12 months visit with %VP data available. | Posted | Median | Standard Deviation | percent of ventricular pacing (%VP) | 12 months post-implantation |
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| 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. | all participants who completed the 1 month visit with %AT/AF burden data available. | Posted | Median | Standard Deviation | Percentage of decreasedAT/AF burden | 1 month post-implantation |
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| Secondary | Change in Percent of Ventricular Pacing | all participants who completed the 12 months visit with %VP data available. | Posted | Median | Standard Deviation | percent of ventricular pacing (%VP) | from 1 month to 12 months post-implantation |
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| Secondary | Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP) | all participants who completed the 12 months visit with %VP data available. | Posted | Count of Participants | Participants | 1 month post-implantation |
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| Secondary | Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB) | all participants who completed the 1 month visit with %VP data available. | Posted | Count of Participants | Participants | No | 1 month post-implantation |
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| Secondary | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB) | all participants who completed the 1 month visit with %VP data available. | Posted | Median | Standard Deviation | percent of ventricular pacing (%VP) | 1 month post-implantation |
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| Secondary | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB) | all participants who completed the 1 month visit with %VP data available. | Posted | Median | Standard Deviation | percent of ventricular pacing (%VP) | 1 month post-implantation |
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| Secondary | Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB) | all participants who completed the 1 month visit with %VP data available. | Posted | Median | Standard Deviation | percent of ventricular pacing (%VP) | 1 month post-implantation |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Managed Ventricular Pacing | Managed Ventricular Pacing (MVP) | 2 | 196 | 2 | 196 | ||
| EG001 | Search AV+ | Search AV+ (SAV+) | 7 | 189 | 3 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (unknown reason) | General disorders | Non-systematic Assessment |
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| Sudden cardiac death (CHD) | General disorders | Non-systematic Assessment |
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| Non-cardiac death (cancer) | General disorders | Non-systematic Assessment |
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| Non-cardiac death (cerebrovascular accident） | General disorders | Non-systematic Assessment |
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| Pocket infection | Infections and infestations | Non-systematic Assessment |
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| Dislodgement of RV lead and reposition of the lead | Surgical and medical procedures | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shu Zhang | Fuwai Hospital | 861088398833 | zsfuwai@vip.163.com |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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