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 - Full Text View

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 (SOS)

This study is not yet open for participant recruitment.

Verified by R&D Cardiologie, September 2007

Sponsored by:	R&D Cardiologie
Information provided by:	R&D Cardiologie
ClinicalTrials.gov Identifier:	NCT00528307

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Device: HIS buldle ablation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:

Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Active Comparator First 3 months of biventricular pacing, second 3 months right ventricular apical pacing	Device: HIS buldle ablation HIS bundle ablation, followed by implant of a biventricular pacemaker
2: Active Comparator First 3 months of right ventricular apical pacing, second 3 months biventricular pacing	Device: HIS buldle ablation HIS bundle ablation, followed by implant of a biventricular pacemaker

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528307

Locations

Netherlands, Utrecht
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM

Sponsors and Collaborators

R&D Cardiologie

Investigators

Principal Investigator:

Lucas VA Boersma, MD, PHD

St. Antonius Hospital

More Information

Study ID Numbers:	RDC-2006-03
Study First Received:	September 11, 2007
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00528307
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by R&D Cardiologie:

myocardial perfusion
His ablation
biventricular pacing
His bundle ablation for atrial fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009