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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)

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
HIS buldle ablation
Sponsored by
R&D Cardiologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring myocardial perfusion, His ablation, biventricular pacing, His bundle ablation for atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

First 3 months of biventricular pacing, second 3 months right ventricular apical pacing

First 3 months of right ventricular apical pacing, second 3 months biventricular pacing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2007
Last Updated
November 4, 2014
Sponsor
R&D Cardiologie
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1. Study Identification

Unique Protocol Identification Number
NCT00528307
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
R&D Cardiologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
myocardial perfusion, His ablation, biventricular pacing, His bundle ablation for atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
First 3 months of biventricular pacing, second 3 months right ventricular apical pacing
Arm Title
2
Arm Type
Active Comparator
Arm Description
First 3 months of right ventricular apical pacing, second 3 months biventricular pacing
Intervention Type
Device
Intervention Name(s)
HIS buldle ablation
Intervention Description
HIS bundle ablation, followed by implant of a biventricular pacemaker
Primary Outcome Measure Information:
Title
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas VA Boersma, MD, PHD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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