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

Aarhus University Hospital Skejby

Status and phase: Completed; Phase 4

Conditions: Atrioventricular Block

Treatments: Other: His lead activated; Other: Septal pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT01019213

07-4-B695-A1464-22378

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Septal pacing

Placebo Comparator group

Description:

Septal lead will be activated.

Treatment:

Other: Septal pacing

His-pacing

Experimental group

Description:

His lead will be activated 80 ms before septal lead

Treatment:

Other: His lead activated