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

Atrioventricular Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019213
• Other study ID #: 07-4-B695-A1464-22378
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2009
• Last updated: May 14, 2012
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Block

Intervention

Other:
• Septal pacing
Septal lead activated
• His lead activated
His lead will be activated 80 ms before septal lead

Locations

Country	Name	City	State
Denmark	Dept. of cardiology Skejby Hospital	AArhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Synchrony by echocardiography		12 months	No
Secondary	New York Heart Association (NYHA) class		12	No
Secondary	6-minute hall walk test		12	No