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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Cryoablation; Procedure: Placebo

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rick Veasey; Phone Number: 4132 0300 131 4500; Email: rick.veasey@nhs.net
• Study Contact Backup: Name: Rajdip Dulai; Phone Number: 4132 0300 131 4500; Email: rajdip.dulai@nhs.net

Study Locations

• United Kingdom
  • Basildon, United Kingdom
    • Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
  • Eastbourne, United Kingdom
    • Eastbourne District General Hospital
  • St Leonards-on-Sea, United Kingdom
    • Conquest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ablation; pulmonary vein isolation	Procedure: Cryoablation; Pulmonary vein isolation with cryoablation
Placebo Comparator: Placebo; placebo procedure	Procedure: Placebo; Placebo procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: East Sussex Hospitals NHS Trust
• Collaborators: Medtronic; Eastbourne Cardiology Research Charity Fund

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): March 4, 2024
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Ablation; Cryoablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 274347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No