- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272762
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (SHAM-PVI)
March 12, 2024 updated by: Rick Veasey, East Sussex Hospitals NHS Trust
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ablation
pulmonary vein isolation
|
Pulmonary vein isolation with cryoablation
|
Placebo Comparator: Placebo
placebo procedure
|
Placebo procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Atrial fibrillation burden using continuous monitoring
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Time Frame: 6 months
|
6 months
|
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Time Frame: 6 months
|
6 months
|
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Time Frame: 6 months
|
6 months
|
Change in AF specific quality of life score between each group (AF-PROMS)
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Comparison of medical treatment ( Antiarrhythmic drug use)
Time Frame: 6 months
|
6 months
|
Comparison of unscheduled use of health care services
Time Frame: 6 months
|
6 months
|
Number of procedure related complications / adverse events
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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