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)

R&D Cardiologie

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: HIS buldle ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00528307

RDC-2006-03

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Device: HIS buldle ablation

2

Active Comparator group

Description:

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

Treatment:

Device: HIS buldle ablation