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Active, Not Recruiting

NCT Number: NCT05856799

Danish Randomized Trial on Leadless vs Transvenous Pacing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology Aarhus University Hospital, Aarhus, Region Midt, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leadless Micra AV Transcatheter Pacing System

Device

Patients are implanted with a leadless Micra AV TPS

Transvenous Azure XT DR dual chamber pacemaker

Device

Patients are implanted with a transvenous Azure XT DR pacemaker

Primary outcomes

  1. Quality of Life by SF36

    Time frame: 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 outcomes

  1. Patient Acceptance by FPAS

    Time frame: 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.

  2. Exercise capacity by 6MWT

    Time frame: 7 months

    Exercise capacity as measured by 6-minute walk test

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Odense University Hospital

Registry information

Official study title

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

Acronym: DANVERS

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 12, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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