Danish Randomized Trial on Leadless vs Transvenous Pacing

NCT05856799 | Active Not Recruiting

• 1 other identifier: DANVERS2303101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

AV Block

Keywords

Leadless Pacing; Cardiac Pacemaker; Cardiac Arrythmia; Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Acceptance by FPAS

  7 months

• Exercise capacity by 6MWT

  7 months

Study Arms (2)

Leadless Pacemaker

ACTIVE COMPARATOR

Implantation with a leadless pacemaker

Device: Leadless Micra AV Transcatheter Pacing System

Transvenous pacemaker

ACTIVE COMPARATOR

Implantation with a transvenous pacemaker

Device: Transvenous Azure XT DR dual chamber pacemaker

Interventions

Leadless Micra AV Transcatheter Pacing System DEVICE

Patients are implanted with a leadless Micra AV TPS

Leadless Pacemaker

Transvenous Azure XT DR dual chamber pacemaker DEVICE

Patients are implanted with a transvenous Azure XT DR pacemaker

Transvenous pacemaker

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (2)

Department of Cardiology Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

Location

Department of Cardiology Odense University Hospital

Odense, Region Syd, 5000, Denmark

Location

MeSH Terms

Conditions

Atrioventricular Block; Heart Diseases

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mads B. Kronborg, DMSc

  Department of Cardiology Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Partly patient and accessor blinded and partly open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Combined parallel and crossover randomized trial

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)