Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

Conditions
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Atrioventricular Block

Intervention / Treatment
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* Other: Septal pacing
* Other: His lead activated


Participation Criteria
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Eligibility Criteria
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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 Pregnant Expected heart surgery < 2 years Expected survival > 2 years Patients that have been His ablated Serious comorbidity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Septal pacing<br>Septal lead will be activated. | Other: Septal pacing<br>* Septal lead activated<br>* Other names: Septal lead;|
| Experimental: His-pacing<br>His lead will be activated 80 ms before septal lead | Other: His lead activated<br>* His lead will be activated 80 ms before septal lead<br>* Other names: His lead;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 months | 
| Synchrony by echocardiography |  | 12 months | 
| New York Heart Association (NYHA) class |  | 12 | 
| 6-minute hall walk test |  | 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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His-pacing