Danish Randomized Trial on Leadless vs Transvenous Pacing

Not Applicable

Recruiting

• Conditions: AV Block
• Interventions: Device: Transvenous Azure XT DR dual chamber pacemaker; Device: Leadless Micra AV Transcatheter Pacing System

• Registration Number: NCT05856799
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Study Start: 2023-08-25
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-11
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvenous pacemaker	Transvenous Azure XT DR dual chamber pacemaker	Implantation with a transvenous pacemaker
Leadless Pacemaker	Leadless Micra AV Transcatheter Pacing System	Implantation with a leadless pacemaker

Primary Outcome Measures

Name	Time	Method
Quality of Life by SF36	7 months	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.

Secondary Outcome Measures

Name	Time	Method
Exercise capacity by 6MWT	7 months	Exercise capacity as measured by 6-minute walk test
Patient Acceptance by FPAS	7 months	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.

Trial Locations

Locations (2)

Department of Cardiology Odense University Hospital; 🇩🇰 Odense, Region Syd, Denmark

Department of Cardiology Aarhus University Hospital; 🇩🇰 Aarhus, Region Midt, Denmark