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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-09-30

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.

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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.

Conditions

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Atrioventricular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Septal pacing

Septal lead will be activated.

Group Type PLACEBO_COMPARATOR

Septal pacing

Intervention Type OTHER

Septal lead activated

His-pacing

His lead will be activated 80 ms before septal lead

Group Type EXPERIMENTAL

His lead activated

Intervention Type OTHER

His lead will be activated 80 ms before septal lead

Interventions

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Septal pacing

Septal lead activated

Intervention Type OTHER

His lead activated

His lead will be activated 80 ms before septal lead

Intervention Type OTHER

Other Intervention Names

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Septal lead His lead

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No