This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 has been terminated.
Sponsor:
Information provided by (Responsible Party):
Vincent van Dijk, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00528307
First received: September 11, 2007
Last updated: November 4, 2014
Last verified: November 2014
  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
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:


Further study details as provided by Vincent van Dijk, 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 ]

Enrollment: 5
Study Start Date: October 2007
Study Completion Date: December 2010
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Sponsors and Collaborators
R&D Cardiologie
Investigators
Principal Investigator: Lucas VA Boersma, MD, PHD St. Antonius Hospital
  More Information

Responsible Party: Vincent van Dijk, MD, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT00528307     History of Changes
Other Study ID Numbers: RDC-2006-03
Study First Received: September 11, 2007
Last Updated: November 4, 2014

Keywords provided by Vincent van Dijk, 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 June 26, 2017