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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Odense University Hospital | OTHER |
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The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leadless Pacemaker | Active Comparator | Implantation with a leadless pacemaker |
|
| Transvenous pacemaker | Active Comparator | Implantation with a transvenous pacemaker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leadless Micra AV Transcatheter Pacing System | Device | Patients are implanted with a leadless Micra AV TPS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life by SF36 | Self-reported health-related quality of life as measured by Short-Form 36 quality of life questionnaire. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptance by FPAS | Self-reported patient acceptance as measured by Florida Patient Acceptance Scale. The scale ranges from 0-100. 0 denotes minimal device acceptance and 100 denotes maximal device acceptance. | 7 months |
| Exercise capacity by 6MWT |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mads B. Kronborg, DMSc | Department of Cardiology Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology Aarhus University Hospital | Aarhus | Region Midt | 8200 | Denmark | ||
| Department of Cardiology Odense University Hospital |
In accordance with Danish and European data protection law
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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Combined parallel and crossover randomized trial
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Partly patient and accessor blinded and partly open label.
| Transvenous Azure XT DR dual chamber pacemaker | Device | Patients are implanted with a transvenous Azure XT DR pacemaker |
|
Exercise capacity as measured by 6-minute walk test |
| 7 months |
| Odense |
| Region Syd |
| 5000 |
| Denmark |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |