His Pacing Feasibility and Cardiac Electrical Activation
NCT04739553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2021-02-04
Summary
This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.
Conditions
- Pacing-Induced Cardiomyopathy
- AV Block
- Heart Failure
Interventions
- DEVICE
-
His Pacing
The patients will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port.
Sponsors & Collaborators
-
Aalborg University Hospital
lead OTHER
Principal Investigators
-
Sam Riahi, MD PhD · Aalborg University Hospital
-
Peter Søgaard, MD DMSc · Aalborg University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-15
- Primary Completion
- 2024-01-31
- Completion
- 2024-01-31
- FDA Device
- Yes
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