Clinical trial NCT04272762: A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation
Official title: A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Ablation
Cryoablation
Lead sponsor: East Sussex Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Eastbourne Cardiology Research Charity Fund
name: Medtronic
First posted: 2020-02-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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%

Primary outcomes:
measure: Atrial fibrillation burden using continuous monitoring
timeFrame: 6 months
Secondary outcomes:
measure: Time to symptomatic atrial tachyarrhythmia stratified by length of episode
timeFrame: 6 months
measure: Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
timeFrame: 6 months
measure: Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
timeFrame: 6 months
measure: Change in AF specific quality of life score between each group (AF-PROMS)
timeFrame: Baseline and 6 months
measure: Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
timeFrame: Baseline and 6 months
measure: Comparison of medical treatment ( Antiarrhythmic drug use)
timeFrame: 6 months
measure: Comparison of unscheduled use of health care services
timeFrame: 6 months
measure: Number of procedure related complications / adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: St Leonards-on-Sea
country: United Kingdom
facility: Conquest Hospital
Study officials:
References:
citation: Dulai R, Furniss SS, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale. Clin Cardiol. 2023 Aug;46(8):973-980. doi: 10.1002/clc.24066. Epub 2023 Jun 13.