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Danish Randomized Trial on Leadless vs Transvenous Pacing (DANVERS)

Primary Purpose

AV Block

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Leadless Micra AV Transcatheter Pacing System
Transvenous Azure XT DR dual chamber pacemaker
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AV Block focused on measuring Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Cardiology Aarhus University HospitalRecruiting
  • Department of Cardiology Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Leadless Pacemaker

Transvenous pacemaker

Arm Description

Implantation with a leadless pacemaker

Implantation with a transvenous pacemaker

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Acceptance by FPAS
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.
Exercise capacity by 6MWT
Exercise capacity as measured by 6-minute walk test

Full Information

First Posted
May 3, 2023
Last Updated
August 25, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05856799
Brief Title
Danish Randomized Trial on Leadless vs Transvenous Pacing
Acronym
DANVERS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Odense University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AV Block
Keywords
Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Combined parallel and crossover randomized trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Partly patient and accessor blinded and partly open label.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leadless Pacemaker
Arm Type
Active Comparator
Arm Description
Implantation with a leadless pacemaker
Arm Title
Transvenous pacemaker
Arm Type
Active Comparator
Arm Description
Implantation with a transvenous pacemaker
Intervention Type
Device
Intervention Name(s)
Leadless Micra AV Transcatheter Pacing System
Intervention Description
Patients are implanted with a leadless Micra AV TPS
Intervention Type
Device
Intervention Name(s)
Transvenous Azure XT DR dual chamber pacemaker
Intervention Description
Patients are implanted with a transvenous Azure XT DR pacemaker
Primary Outcome Measure Information:
Title
Quality of Life by SF36
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Patient Acceptance by FPAS
Description
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.
Time Frame
7 months
Title
Exercise capacity by 6MWT
Description
Exercise capacity as measured by 6-minute walk test
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik L. Bjerre, MD
Phone
30311345
Ext
+45
Email
henrikbjerre@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mads B. Kronborg, DMSc
Phone
29896776
Ext
+45
Email
madskron@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads B. Kronborg, DMSc
Organizational Affiliation
Department of Cardiology Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology Aarhus University Hospital
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik L. Bjerre, MD
Phone
30311345
Ext
+45
Email
henrikbjerre@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Mads B. Kronborg, DMSc
Phone
29896776
Ext
+45
Email
madskron@rm.dk
Facility Name
Department of Cardiology Odense University Hospital
City
Odense
State/Province
Region Syd
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens B. Johansen, PhD
Phone
26818248
Ext
+45
Email
brock@dadlnet.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In accordance with Danish and European data protection law

Learn more about this trial

Danish Randomized Trial on Leadless vs Transvenous Pacing

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