Danish Randomized Trial on Leadless vs Transvenous Pacing (DANVERS)

University of Aarhus

Status: Enrolling

Conditions: AV Block

Treatments: Device: Transvenous Azure XT DR dual chamber pacemaker; Device: Leadless Micra AV Transcatheter Pacing System

Study type: Interventional

Funder types: Other

Identifiers

NCT05856799

DANVERS2303101

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Leadless Pacemaker

Active Comparator group

Description:

Implantation with a leadless pacemaker

Treatment:

Device: Leadless Micra AV Transcatheter Pacing System

Transvenous pacemaker

Active Comparator group

Description:

Implantation with a transvenous pacemaker

Treatment:

Device: Transvenous Azure XT DR dual chamber pacemaker