Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atrioventricular Block
- Sponsor
- Aarhus University Hospital Skejby
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Left ventricular ejection fraction (LVEF)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction.
Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative compared to RV septal septal pacing in patients with AV-block.
Detailed Description
Conventional right ventricular apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction. The aims of our crossover, double-blinded, randomized study is to evaluate the feasibility and long-term safety of permanent His pacing and to compare the effects on left ventricular ejection fraction of permanent His pacing with those of conventional right septal stimulation after 12 months treatment in patients with 2nd or 3rd degree AV-block.
Investigators
Mads Brix Kronborg
Dr.
Aarhus University Hospital Skejby
Eligibility Criteria
Inclusion Criteria
- •2nd or 3rd degree Av block
Exclusion Criteria
- •QRS \> or = 120 ms
- •Indication for cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD)
- •chronic atrial fibrillation
- •Expected heart surgery \< 2 years
- •Expected survival \> 2 years
- •Patients that have been His ablated
- •Serious comorbidity
Outcomes
Primary Outcomes
Left ventricular ejection fraction (LVEF)
Time Frame: 12 months
Secondary Outcomes
- Quality of life(12 months)
- Synchrony by echocardiography(12 months)
- New York Heart Association (NYHA) class(12)
- 6-minute hall walk test(12)