Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
NCT05889208 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2023-06-05
Summary
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:
* Prophylactic pacemaker implantation prior TAVI
* Conservative strategy
Conditions
- Aortic Stenosis
- Right Bundle-Branch Block
Interventions
- DEVICE
-
Prophylactic pacemaker implantation
Pacemaker implantation prior the TAVI-procedure
Sponsors & Collaborators
-
Aalborg University Hospital
lead OTHER
Principal Investigators
-
Ashkan Eftekhari · Aalborg University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2026-12-01
- Completion
- 2027-12-01
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