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

Phase 4

Completed

• Conditions: Atrioventricular Block
• Interventions: Other: Septal pacing; Other: His lead activated

• Registration Number: NCT01019213
• Lead Sponsor: Aarhus University Hospital Skejby

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Septal pacing	Septal pacing	Septal lead will be activated.
His-pacing	His lead activated	His lead will be activated 80 ms before septal lead

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF)	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months
Synchrony by echocardiography	12 months
New York Heart Association (NYHA) class	12
6-minute hall walk test	12

Trial Locations

Locations (1)

Dept. of cardiology Skejby Hospital; 🇩🇰 AArhus, Denmark