Danish Randomized Trial on Leadless vs Transvenous Pacing

Study Overview
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Brief Summary
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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.

Official Title
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Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block

Conditions
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AV Block

Intervention / Treatment
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* Device: Leadless Micra AV Transcatheter Pacing System
* Device: Transvenous Azure XT DR dual chamber pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing >80% of the time, Age 75 years or older Intact sinus node function Expected survival more than 12 months based on clinical evaluation Able to provide informed consent Exclusion criteria: Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT. Persistent, or chronic atrial fibrillation Reversible AVB Transient AVB due to ongoing ischemia Heart failure NYHA class III-IV Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class Indication for primary or secondary prophylactic ICD implantation Acute myocardial infarction (AMI) within 3 months Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity Expected survival < 12 months based on clinical evaluation Performing high intensity sport Participation in another trial with experimental treatment Contraindication against device implantation (e.g., concurrent infection) Failure to provide informed consent

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Combined parallel and crossover randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Leadless Pacemaker<br>Implantation with a leadless pacemaker | Device: Leadless Micra AV Transcatheter Pacing System<br>* Patients are implanted with a leadless Micra AV TPS<br>|
| Active Comparator: Transvenous pacemaker<br>Implantation with a transvenous pacemaker | Device: Transvenous Azure XT DR dual chamber pacemaker<br>* Patients are implanted with a transvenous Azure XT DR pacemaker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Exercise capacity as measured by 6-minute walk test | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease