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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by R&D Cardiologie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00528307
First received: September 11, 2007
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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
St Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435CM
Contact: Lucas VA Boersma, MD, PhD     +31 30 6092278     v.van.dijk@antonius.net    
Principal Investigator: Lucas VA Boersma, MD, PhD            
Sponsors and Collaborators
R&D Cardiologie
Investigators
Principal Investigator: Lucas VA Boersma, MD, PHD St. Antonius Hospital
  More Information

No publications provided

Responsible Party: Lucas VA Boersma, MD PhD, St Antonius Hospital
ClinicalTrials.gov Identifier: NCT00528307     History of Changes
Other Study ID Numbers: RDC-2006-03
Study First Received: September 11, 2007
Last Updated: June 9, 2010
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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013