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

East Sussex Hospitals NHS Trust

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Cryoablation; Procedure: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04272762

274347

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Ablation

Active Comparator group

Description:

pulmonary vein isolation

Treatment:

Procedure: Cryoablation

Placebo

Placebo Comparator group

Description:

placebo procedure

Treatment:

Procedure: Placebo