Atrial FibrillationSHAM-PVINCT04272762
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation
A study testing Cryoablation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 3 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 23 Jan 2020to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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%
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
Basildon
Eastbourne District General Hospital
Eastbourne
Conquest Hospital
Saint Leonards-on-Sea
About this study
Official title: 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
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoablation, Placebo
- Keywords
- Atrial Fibrillation, Ablation, Cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Pulmonary vein isolation with cryoablation
PlaceboProcedure or surgery
Placebo procedure
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Active comparator | pulmonary vein isolation Receives: Procedure: Cryoablation |
| Placebo | Placebo comparator | placebo procedure Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation burden using continuous monitoring
Measured: 6 months
Secondary outcomes (8)
Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Measured: 6 months
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Measured: 6 months
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Measured: 6 months
Change in AF specific quality of life score between each group (AF-PROMS)
Measured: Baseline and 6 months
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
Measured: Baseline and 6 months
Comparison of medical treatment ( Antiarrhythmic drug use)
Measured: 6 months
Comparison of unscheduled use of health care services
Measured: 6 months
Number of procedure related complications / adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start23 Jan 2020
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Eastbourne Cardiology Research Charity Fund, Medtronic
- Responsible party
- Principal investigator, Rick Veasey, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272762
- Sponsor's protocol ID
- 274347
- Acronym
- SHAM-PVI
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2020
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37309845Williams JL, Bizanti A, Khanna A, Nass O, Hyun S, Fernandez J. Nonspecific Effects in Atrial Fibrillation Ablation: Insights From SHAM-PVI and Other Sham-Controlled Trials, Methodology Corner. JACC Adv. 2026 Aug 20;5(9):103130. doi: 10.1016/j.jacadv.2026.103130. Online ahead of print.
PubMed 42623957Dulai R, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. 2024 Sep 2;332(14):1165-73. doi: 10.1001/jama.2024.17921. Online ahead of print.
PubMed 39221629
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)
- ClinicalTrials.gov ID
- NCT04272762
- Acronym / sponsor ID
- SHAM-PVI / 274347
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ablation, Cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Eastbourne Cardiology Research Charity Fund, Medtronic
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Active comparator | Procedure: Cryoablationpulmonary vein isolation |
| Placebo | Placebo comparator | Procedure: Placeboplacebo procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationPulmonary vein isolation with cryoablation | Procedure or surgery | Ablation |
| PlaceboPlacebo procedure | Procedure or surgery | Placebo |
Primary outcome
Atrial fibrillation burden using continuous monitoring
Time frame: 6 months
8 secondary outcomes
Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Time frame: 6 months
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Time frame: 6 months
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Time frame: 6 months
Change in AF specific quality of life score between each group (AF-PROMS)
Time frame: 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
Comparison of medical treatment ( Antiarrhythmic drug use)
Time frame: 6 months
Comparison of unscheduled use of health care services
Time frame: 6 months
Number of procedure related complications / adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 37309845Dulai 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.
- Derived from this study: PubMed 42623957Williams JL, Bizanti A, Khanna A, Nass O, Hyun S, Fernandez J. Nonspecific Effects in Atrial Fibrillation Ablation: Insights From SHAM-PVI and Other Sham-Controlled Trials, Methodology Corner. JACC Adv. 2026 Aug 20;5(9):103130. doi: 10.1016/j.jacadv.2026.103130. Online ahead of print.
- Derived from this study: PubMed 39221629Dulai R, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. 2024 Sep 2;332(14):1165-73. doi: 10.1001/jama.2024.17921. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden using continuous monitoring (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272762, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.