Danish Randomized Trial on Leadless vs Transvenous Pacing

AV Block Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856799
• Other study ID #: DANVERS2303101
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: Henrik L. Bjerre, MD
• Phone: 30311345
• Email: henrikbjerre[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• AV Block

Intervention

Device:
• Leadless Micra AV Transcatheter Pacing System
Patients are implanted with a leadless Micra AV TPS
• Transvenous Azure XT DR dual chamber pacemaker
Patients are implanted with a transvenous Azure XT DR pacemaker

Locations

Country	Name	City	State
Denmark	Department of Cardiology Aarhus University Hospital	Aarhus	Region Midt
Denmark	Department of Cardiology Odense University Hospital	Odense	Region Syd

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 months
Secondary	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.	7 months
Secondary	Exercise capacity by 6MWT	Exercise capacity as measured by 6-minute walk test	7 months