NCT04272762Completed
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)
Source: ClinicalTrials.gov · Last updated 13 Mar 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 12 Feb 2020
- Start date
- 23 Jan 2020
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Diseases
- Atrial fibrillation
- NCT number
- NCT04272762
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 23 Jan 2020 to the primary completion date, 4 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrium catheter or surgical atrial fibrillation ablation
- Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
- Myocardial infarction within three months prior to enrolment.
- Stroke or transient ischemic attack (TIA) within three months prior to enrolment
Other illness
- Patients with other arrhythmias requiring ablative therapy
- Awaiting cardiac surgery or PCI
- 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
- Medical conditions limiting expected survival to \<1 year
- History of claustrophobia or panic attacks
Lab values
- Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min)
- Left ventricular ejection fraction (LVEF) less than 35%
Other
- Long term persistent AF (continuous episode lasting more than 1)
- Left atrium (LA) ≥5.5 cm
- Any untreated or uncontrolled hyperthyroidism or hypothyroidism
- Patients with metallic prosthetic valves
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre Coordinator of this site? Confirm its status | Basildon | United Kingdom | Unknown status |
| Eastbourne District General Hospital Coordinator of this site? Confirm its status | Eastbourne | United Kingdom | Unknown status |
| Conquest Hospital Coordinator of this site? Confirm its status | Saint Leonards-on-Sea | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.