BradycardiaCOMPARENCT01039467
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
A study testing Medtronic Adapta Dual Chamber Pacemaker in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 30 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Medtronic Adapta Dual Chamber Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 30 sitesChina
- Study dates
- Jun 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Patient has persistent atrial fibrillation (AF)
- Patient has neurogenic syncope
- Patient has carotid sinus syndrome
- Patient has hypertrophic obstructive cardiomyopathy
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
3rd Hospital of Beijing University
Beijing, Beijing Municipality
Anzhen Hospital
Beijing, Beijing Municipality
Beijing Hospital
Beijing, Beijing Municipality
Fuwai Hospital
Beijing, Beijing Municipality
2nd Hospital of Jilin University
Changchun, Jilin
Xiangya Second Hospital, Central South University
Changsha, Hunan
Fujian Province Hospital
Fuzhou, Fujian
1st Hospital of Zhongshan Medical University
Guangzhou, Guangdong
2nd Hospital of Zhongshan Medical University
Guangzhou, Guangdong
Guangdong Province People's Hospital
Guangzhou, Guangdong
1st Hospital of Medical College, Zhejiang University
Hangzhou, Zhejiang
2nd Hospital of Medical College, Zhejiang University
Hangzhou, Zhejiang
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Zhejiang Hospital
Hangzhou, Zhejiang
1st Hospital of Kunming Medical College
Kunming, Yunnan
Yunnan Province 1st People's Hospital
Kunming, Yunnan
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Affiliated Hospital of Qingdao Medical College
Qingdao, Shandong
Shanghai Huadong Hospital
Shanghai, Shanghai Municipality
Shanghai Minhang District Hospital
Shanghai, Shanghai Municipality
Shanghai First People's Hospital
Shanghai
Liaoning Province People's Hospital
Shenyang, Liaoning
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Xinjiang Automatic District Hospital
Ürümqi, Xinjiang
Wuhan Asian Heart Hospital
Wuhan, Hubei
Wuhan Union Hospital
Wuhan, Hubei
Yuxi People's Hospital
Yuxi, Yunnan
1st Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
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.
Read the 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.
- Conditions
- Bradycardia
- Being tested
- Medtronic Adapta Dual Chamber Pacemaker
- Keywords
- Managed Ventricular Pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Adapta Dual Chamber PacemakerDevice
Medtronic Adapta Dual Chamber Pacemaker
| Study group | Role | What they receive |
|---|---|---|
| Managed Ventricular Pacing | Active comparator | Managed Ventricular Pacing group: programmed on Receives: Device: Medtronic Adapta Dual Chamber Pacemaker |
| Search AV+ | Active comparator | Search AV+: programmed on Receives: Device: Medtronic Adapta Dual Chamber Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
Measured: 1 month post-implantation
Secondary outcomes (8)
Percent of Ventricular Pacing
Measured: 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.
Measured: 1 month post-implantation
Change in Percent of Ventricular Pacing
Measured: from 1 month to 12 months post-implantation
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
Measured: 1 month post-implantation
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
Measured: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
Measured: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
Measured: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)
Measured: 1 month post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shu Zhang, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039467
- Sponsor's protocol ID
- COMPARE Study
- Acronym
- COMPARE
- Status last verified
- Jan 2020
- First submitted
- 23 Dec 2009
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
- ClinicalTrials.gov ID
- NCT01039467
- Acronym / sponsor ID
- COMPARE / COMPARE Study
- Conditions
- Bradycardia
- Keywords
- Managed Ventricular Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managed Ventricular Pacing | Active comparator | Device: Medtronic Adapta Dual Chamber PacemakerManaged Ventricular Pacing group: programmed on |
| Search AV+ | Active comparator | Device: Medtronic Adapta Dual Chamber PacemakerSearch AV+: programmed on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Adapta Dual Chamber PacemakerMedtronic Adapta Dual Chamber Pacemaker | Device | Managed Ventricular Pacing, Search AV+ |
Primary outcome
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
Time frame: 1 month post-implantation
8 secondary outcomes
Percent of Ventricular Pacing
Time frame: 12 months post-implantation
Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant
Time frame: 1 month post-implantation
Change in Percent of Ventricular Pacing
Time frame: from 1 month to 12 months post-implantation
Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)
Time frame: 1 month post-implantation
Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)
Time frame: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)
Time frame: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)
Time frame: 1 month post-implantation
Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)
Time frame: 1 month post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu Zhang, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Adapta Dual Chamber Pacemaker in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+ (time frame: 1 month post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.