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

Atrial Fibrillation Clinical Trial

— SHAM-PVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272762
• Other study ID #: 274347
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: March 4, 2024

Study information

• Verified date: March 2024
• Source: East Sussex Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 4, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ß-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%

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Cryoablation
Pulmonary vein isolation with cryoablation
• Placebo
Placebo procedure

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
East Sussex Hospitals NHS Trust	Eastbourne Cardiology Research Charity Fund, Medtronic

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden using continuous monitoring		6 months
Secondary	Time to symptomatic atrial tachyarrhythmia stratified by length of episode		6 months
Secondary	Time to asymptomatic atrial tachyarrhythmia stratified by length of episode		6 months
Secondary	Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode		6 months
Secondary	Change in AF specific quality of life score between each group (AF-PROMS)		Baseline and 6 months
Secondary	Change in health related quality of life in each group (36-Item Short Form Survey Instrument )		Baseline and 6 months
Secondary	Comparison of medical treatment ( Antiarrhythmic drug use)		6 months
Secondary	Comparison of unscheduled use of health care services		6 months
Secondary	Number of procedure related complications / adverse events		6 months