Status:
COMPLETED
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation
Lead Sponsor:
East Sussex Hospitals NHS Trust
Collaborating Sponsors:
Eastbourne Cardiology Research Charity Fund
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
January 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04272762
Start Date
January 23 2020
End Date
March 4 2024
Last Update
March 13 2024
Active Locations (3)
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1
Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
Basildon, United Kingdom
2
Eastbourne District General Hospital
Eastbourne, United Kingdom
3
Conquest Hospital
Saint Leonards-on-Sea, United Kingdom