A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Placebo; Procedure: Cryoablation

• Registration Number: NCT04272762
• Lead Sponsor: East Sussex Hospitals NHS Trust

Brief Summary

This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Status Verified: 2024-03
• Primary Completion: 2024-03-04
• Study Completion: 2024-03-04
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age greater than or equal to 18 years
• Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).
• Referred for catheter ablation

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Exclusion Criteria

• Long term persistent AF (continuous episode lasting more than 1)
• Prior left atrium catheter or surgical atrial fibrillation ablation
• Patients with other arrhythmias requiring ablative therapy
• Left atrium (LA) ≥5.5 cm
• Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
• Awaiting cardiac surgery or PCI
• Myocardial infarction within three months prior to enrolment.
• Stroke or transient ischemic attack (TIA) within three months prior to enrolment
• Unstable angina
• Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
• Any condition contraindicating chronic anticoagulation
• Any untreated or uncontrolled hyperthyroidism or hypothyroidism
• Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min)
• Patients with metallic prosthetic valves
• Pregnant or breastfeeding women
• Medical conditions limiting expected survival to <1 year
• History of claustrophobia or panic attacks
• Left ventricular ejection fraction (LVEF) less than 35%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo procedure
Ablation	Cryoablation	pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation burden using continuous monitoring	6 months

Secondary Outcome Measures

Name	Time	Method
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode	6 months
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode	6 months
Comparison of unscheduled use of health care services	6 months
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )	Baseline and 6 months
Comparison of medical treatment ( Antiarrhythmic drug use)	6 months
Number of procedure related complications / adverse events	6 months
Change in AF specific quality of life score between each group (AF-PROMS)	Baseline and 6 months
Time to symptomatic atrial tachyarrhythmia stratified by length of episode	6 months

Trial Locations

Locations (3)

Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre; 🇬🇧 Basildon, United Kingdom

Eastbourne District General Hospital; 🇬🇧 Eastbourne, United Kingdom

Conquest Hospital; 🇬🇧 St Leonards-on-Sea, United Kingdom