Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had a heart attack that caused scarring of the heart muscle (ischemic cardiomyopathy), or people with heart muscle scarring from a non-blockage-related cause confirmed by heart imaging (non-ischemic cardiomyopathy).
• People who have had at least one episode of a sustained, fast abnormal heart rhythm originating in the lower chambers of the heart (ventricular tachycardia lasting more than 30 seconds, or stopped by their defibrillator device) in the past 6 months.
• People whose ventricular tachycardia has continued to occur despite trying certain heart rhythm medications or receiving shocks from their implanted defibrillator device.
• People who have had an implanted defibrillator device (ICD or CRT-D) in place for at least 3 months before the procedure.
• People aged 18 to 85 years old.
• People who are willing and able to give their informed consent to participate.
• People who are willing and able to attend and complete all required appointments and tests before, during, and after the study.

Who may not be able to join:

• People experiencing constant, uncontrolled ventricular tachycardia that requires mechanical support to maintain blood pressure before the procedure.
• People with an unstable form of irregular heart rhythm called polymorphic ventricular tachycardia or ventricular fibrillation.
• People whose abnormal heart rhythm is caused by certain specific conditions, including a type that originates without structural heart disease (idiopathic VT), abnormal electrical triggering in the heart, specific genetic mutations (lamin or titin), or a reversible cause such as an electrolyte imbalance, active thyroid disease, or certain medications.
• People with non-ischemic cardiomyopathy who have had active heart muscle inflammation (such as myocarditis) within the 120 days before the procedure.
• People whose abnormal heart rhythm is thought to be caused by a genetic electrical channel disorder (channelopathy).
• People who have had more than two prior ablation procedures for ventricular tachycardia at any point, more than one such procedure within the past 12 months, or any such procedure within the past 4 weeks.
• People diagnosed with sarcoidosis.
• People with a thickened heart muscle condition (hypertrophic cardiomyopathy), unless it is specifically caused by an apical aneurysm.
• People with unstable chest pain (unstable angina).
• People with currently active reduced blood supply to the heart muscle (active myocardial ischemia).
• People who have had a certain type of heart attack (Type 1 myocardial infarction) within the past 2 months.
• People who have had a procedure to open blocked heart arteries (percutaneous coronary intervention) within the past 2 months.
• People who have had heart surgery within the past 3 months.
• People whose heart pumping function is very severely reduced (left ventricular ejection fraction below 15%).
• People with the most severe level of heart failure symptoms (NYHA Class IV).
• People whose heart failure is currently in an unstable or worsening state (decompensated heart failure).
• People who are currently receiving, or are expected to need before the procedure, a type of life support machine that circulates blood outside the body (ECMO).
• People who have, or are planned to have, a mechanical heart pump device (ventricular assist device) implanted.
• People with severe narrowing or severe leaking of the aortic or mitral heart valves.
• People who have an artificial (prosthetic) replacement valve in the aortic or mitral position.
• People with advanced chronic lung disease who require oxygen at home.
• People who have a blood clot, tumour, or other abnormality inside the heart that would prevent safe access with catheters during the procedure.
• People who have had a stroke or mini-stroke (TIA) within the past 6 months, or who have lasting neurological effects from a prior stroke.
• People with a blood clot detected by imaging inside the left side of the heart.
• People with a serious bleeding disorder, clotting disorder, or a very low platelet count (below 80,000).
• People who cannot safely take blood-thinning medication (anticoagulation).
• People with end-stage kidney disease requiring dialysis.
• People who are currently acutely unwell, have an active infection, or have sepsis.
• People whose life expectancy is estimated to be less than 12 months.
• People who are known to be pregnant or breastfeeding, or people of childbearing potential who are not using a reliable form of contraception or abstinence.
• People with a body mass index (BMI) greater than 45.
• People with a known active dependency on drugs or alcohol.
• People who are currently participating, or plan to participate, in another study of a drug, device, or biological treatment during this study, unless pre-approved by the study sponsor.
• People considered vulnerable, such as prisoners, people with certain mental or physical disabilities, or people under legal guardianship (confirm with trial site).
• People who, in the opinion of the treating investigator, have any other condition that would make participation unsafe or make completing the study requirements unlikely.

Important: Always verify eligibility with the trial site directly before applying.