Cardiomyopathy 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:
- You have been diagnosed with, and your doctor has recommended, a heart procedure called catheter ablation to treat an irregular heartbeat — specifically ventricular tachycardia, premature ventricular complexes, atrial tachycardia, or atrial fibrillation (having had a previous ablation procedure does not disqualify you).
- At least one episode of your irregular heartbeat has been recorded by a heart monitor (such as an ECG, Holter monitor, implanted device, or similar) within the past 12 months.
- You are 18 years of age or older.
- You are willing and able to sign a consent form agreeing to take part in the study.
- You are able and willing to attend all required appointments and follow-up visits before, during, and after the study.
Who may not be able to join:
- Your irregular heartbeat is caused by a treatable or temporary condition, such as an electrolyte imbalance, thyroid disease, or a cause not related to the heart.
- You need a procedure involving the left side of your heart, and a scan has shown that a specific part of your heart (left atrium) is larger than 55mm.
- Your heart's pumping strength (called ejection fraction) is at or below 25% and you have a ventricular (lower chamber) irregular heartbeat.
- Your heart's pumping strength is at or below 40% and you have an atrial (upper chamber) irregular heartbeat.
- A scan taken within 24 hours before the procedure found a blood clot inside your heart.
- You cannot take blood-thinning medications such as heparin, warfarin, or dabigatran.
- You have a history of abnormal blood clotting or bleeding problems.
- You have had a heart attack within the past 2 months.
- You have had a blood clot or a mini-stroke (TIA) within the past 12 months.
- Your heart failure is not controlled, or your doctor has classified your heart failure as the most severe level (NYHA Class IV).
- You have had a pacemaker, heart defibrillator, or heart closure device implanted within the past 6 weeks.
- You have a known allergy to contrast dye used in medical imaging that cannot be treated.
- You currently have an active illness, infection, or sepsis (a serious body-wide infection).
- You have a heart tumour, abnormal tissue, or a physical barrier inside your heart that would make the procedure impossible.
- You have a significant birth defect or other serious medical condition that your doctor believes would make participation unsafe (confirm with trial site).
- You have previously had a heart valve procedure or surgery, including valve repair or replacement, or have an artificial heart valve.
- You currently have, or have had within the last 7 days, a temporary heart support device (such as an Impella) in place.
- You have had any heart surgery, including a coronary artery procedure (PCI), within the past 2 months.
- You have had a procedure to close a hole between the upper chambers of your heart within the past 6 weeks.
- You have a condition that prevents doctors from accessing your blood vessels to carry out the procedure.
- You are pregnant, breastfeeding, or of childbearing age and plan to become pregnant during the study.
- You are considered a vulnerable individual requiring special protections (confirm with trial site).
- You are currently taking part in another clinical study testing a different medical device or drug.
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: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Phone: 844-434-4210
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
Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping; Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.