Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SOS  

Official title:

Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00528307
• Other study ID #: RDC-2006-03
• Status: Terminated
• Phase: N/A
• First received: September 11, 2007
• Last updated: November 4, 2014
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: November 2014
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal to nearly normal LVF (EF > 40%)

• Drug-refractory, persistent or permanent atrial fibrillation

• Referred for His ablation

Exclusion Criteria:

• Unwilling or unable to sign the informed consent

• Life expectancy < 1year from non-cardiac causes

• Previous myocardial infarction

• Previous coronary bypass surgery

• Poor left ventricle function (EF< 40%) from any cause

• Symptomatic obstructive coronary artery disease

• Poor ultra sound imaging quality.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• HIS buldle ablation
HIS bundle ablation, followed by implant of a biventricular pacemaker

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
R&D Cardiologie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.		6 months	No