- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856799
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
Status
Recruiting
Conditions
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
- Name: Henrik L. Bjerre, MD
- Phone Number: +45 30311345
- Email: henrikbjerre@clin.au.dk
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:
- Henrik L. Bjerre, MD
- Phone Number: +45 30311345
- Email: henrikbjerre@clin.au.dk
-
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:
- Jens B. Johansen, PhD
- Phone Number: +45 26818248
- Email: brock@dadlnet.dk
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DANVERS2303101
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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