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

NCT ID: NCT00528307

Last Updated: 2014-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

HIS buldle ablation

Intervention Type DEVICE

HIS bundle ablation, followed by implant of a biventricular pacemaker

2

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

Group Type ACTIVE_COMPARATOR

HIS buldle ablation

Intervention Type DEVICE

HIS bundle ablation, followed by implant of a biventricular pacemaker

Interventions

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HIS buldle ablation

HIS bundle ablation, followed by implant of a biventricular pacemaker

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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R&D Cardiologie

OTHER

Sponsor Role lead

Responsible Party

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Vincent van Dijk

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucas VA Boersma, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RDC-2006-03

Identifier Type: -

Identifier Source: org_study_id

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