Danish Randomized Trial on Leadless vs Transvenous Pacing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2026-06-30

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.

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Detailed Description

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Conditions

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AV Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Combined parallel and crossover randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Partly patient and accessor blinded and partly open label.

Study Groups

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Leadless Pacemaker

Implantation with a leadless pacemaker

Group Type ACTIVE_COMPARATOR

Leadless Micra AV Transcatheter Pacing System

Intervention Type DEVICE

Patients are implanted with a leadless Micra AV TPS

Transvenous pacemaker

Implantation with a transvenous pacemaker

Group Type ACTIVE_COMPARATOR

Transvenous Azure XT DR dual chamber pacemaker

Intervention Type DEVICE

Patients are implanted with a transvenous Azure XT DR pacemaker

Interventions

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Leadless Micra AV Transcatheter Pacing System

Patients are implanted with a leadless Micra AV TPS

Intervention Type DEVICE

Transvenous Azure XT DR dual chamber pacemaker

Patients are implanted with a transvenous Azure XT DR pacemaker

Intervention Type DEVICE

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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No