Danish Randomized Trial on Leadless vs Transvenous Pacing (DANVERS)

August 25, 2023 updated by: University of Aarhus

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

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mads B. Kronborg, DMSc
  • Phone Number: +45 29896776
  • Email: madskron@rm.dk

Study Locations

    • Region Midt
      • Aarhus, Region Midt, Denmark, 8200
        • Recruiting
        • Department of Cardiology Aarhus University Hospital
        • Contact:
        • Contact:
          • Mads B. Kronborg, DMSc
          • Phone Number: +45 29896776
          • Email: madskron@rm.dk
    • Region Syd
      • Odense, Region Syd, Denmark, 5000
        • Not yet recruiting
        • Department of Cardiology Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Leadless Pacemaker
Implantation with a leadless pacemaker
Patients are implanted with a leadless Micra AV TPS
Active Comparator: Transvenous pacemaker
Implantation with a transvenous pacemaker
Patients are implanted with a transvenous Azure XT DR pacemaker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity by 6MWT
Time Frame: 7 months
Exercise capacity as measured by 6-minute walk test
7 months
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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mads B. Kronborg, DMSc, Department of Cardiology Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In accordance with Danish and European data protection law

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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