Clinical trial NCT05856799: Danish Randomized Trial on Leadless vs Transvenous Pacing
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
Overall status: RECRUITING
Phase: NA
Conditions: AV Block
Keywords: Leadless Pacing
Cardiac Pacemaker
Cardiac Arrythmia
Heart Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
First posted: 2023-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Combined parallel and crossover randomized trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Quality of Life by SF36
timeFrame: 7 months
Secondary outcomes:
measure: Patient Acceptance by FPAS
timeFrame: 7 months
measure: Exercise capacity by 6MWT
timeFrame: 7 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology Aarhus University Hospital
state: Region Midt
city: Odense
country: Denmark
facility: Department of Cardiology Odense University Hospital
state: Region Syd
Study officials:
affiliation: Department of Cardiology Aarhus University Hospital
name: Mads B. Kronborg, DMSc
role: PRINCIPAL_INVESTIGATOR
References: