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)

November 4, 2014 updated by: Vincent van Dijk, R&D Cardiologie
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R&D Cardiologie

Investigators

  • Principal Investigator: Lucas VA Boersma, MD, PhD, St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-2006-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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