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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Cryoablation
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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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 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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ablation<br>pulmonary vein isolation | Procedure: Cryoablation<br>* Pulmonary vein isolation with cryoablation<br>|
| Placebo Comparator: Placebo<br>placebo procedure | Procedure: Placebo<br>* Placebo procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation burden using continuous monitoring |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptomatic atrial tachyarrhythmia stratified by length of episode |  | 6 months | 
| 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 | 
| Change in AF specific quality of life score between each group (AF-PROMS) |  | Baseline and 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 | 
| Comparison of unscheduled use of health care services |  | 6 months | 
| Number of procedure related complications / adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Ablation, Cryoablation