AV Block
Conditions
Keywords
Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease
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.
Interventions
DEVICELeadless Micra AV Transcatheter Pacing System
Patients are implanted with a leadless Micra AV TPS
DEVICETransvenous Azure XT DR dual chamber pacemaker
Patients are implanted with a transvenous Azure XT DR pacemaker
Sponsors
University of Aarhus
Aarhus University Hospital
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Partly patient and accessor blinded and partly open label.
Intervention model description
Combined parallel and crossover randomized trial
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life by SF36 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptance by FPAS | 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. |
| Exercise capacity by 6MWT | 7 months | Exercise capacity as measured by 6-minute walk test |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORMads B. Kronborg, DMSc
Department of Cardiology Aarhus University Hospital
Outcome results
None listed