Atrial Fibrillation Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with paroxysmal atrial fibrillation (a type of irregular heartbeat that starts and stops on its own) or persistent atrial fibrillation (an irregular heartbeat lasting more than 7 days but less than 1 year), confirmed by a doctor's note and heart rhythm recordings
- People who are planning to have their first ablation procedure (a treatment to correct the irregular heartbeat) using a specific device called the Volt PFA Catheter
- People whose atrial fibrillation has not responded well to, or who cannot tolerate or take, at least one type of heart rhythm medication
- People aged 18 or older
- People who are able and willing to attend all required appointments before, during, and after the procedure, including follow-up visits
- People who have been fully informed about the trial and have signed a written consent form approved by the relevant ethics committee
Who may not be able to join:
- People whose irregular heartbeat is caused by a treatable or temporary condition, such as a thyroid problem, alcohol intoxication, an imbalance of body minerals, untreated severe sleep apnea, or major surgery in the past 90 days
- People known to have a blood clot in the heart
- People whose heart pumping function is significantly reduced (left ventricular ejection fraction below 35%), as measured by an ultrasound of the heart within the past 360 days
- People with severe heart failure (classified as New York Heart Association class III or IV)
- People who are pregnant, breastfeeding, or planning to become pregnant during the trial follow-up period
- People who have had heart surgery involving an incision in the heart's chambers within the past 30 days
- People who have had a heart attack, a heart artery procedure, or heart bypass or valve surgery within the past 90 days
- People with unstable chest pain (unstable angina)
- People who have had a stroke or a mini-stroke (TIA) within the past 90 days
- People who are expected to need corrective heart surgery within 180 days after the procedure
- People with a history of blood clotting or bleeding disorders
- People who cannot safely take long-term blood-thinning medication
- People who cannot receive heparin (a blood-thinning medication) or a suitable alternative during the procedure
- People who have previously had a surgical or catheter-based ablation procedure on the left side of the heart, or have had a device implanted to close off a part of the heart called the left atrial appendage
- People with a severe leaking of the mitral valve (one of the heart's valves) meeting specific measurements (confirm with trial site)
- People who have previously had a tricuspid or mitral heart valve replaced or repaired
- People with artificial (prosthetic) heart valves
- People with a type of benign heart tumour called a myxoma
- People who have a surgical patch or baffle between the upper chambers of the heart, as this can affect a required part of the procedure
- People with a narrowing or blockage in one of the pulmonary veins (blood vessels connecting the lungs to the heart)
- People with rheumatic heart disease
- People with a condition called hypertrophic cardiomyopathy (thickening of the heart muscle)
- People diagnosed with amyloidosis (a condition where abnormal proteins build up in organs, including the heart)
- People with an active infection in the body
- People with kidney failure who require dialysis
- People with severe lung disease or other serious, ongoing lung or breathing conditions
- People who already have a left atrial appendage closure device implanted
- People who are currently taking part in another clinical trial that could affect the results of this study
- People who are unlikely to survive for the 12-month follow-up period
- People with other medical, physical, social, or psychological conditions that the trial doctor believes would affect their ability to participate safely or complete the trial
- People who do not have legal capacity to consent to participation
- People who are unable to read or write
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sarah C Kammer, Abbott Medical Devices
Phone: +3222006511
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF; Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.; Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.