Comparing cryoballoon ablation and medication for atrial fibrillation in heart failure patients

Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories

This study is testing whether a procedure called cryoballoon ablation works better than medication for helping heart failure patients with atrial fibrillation feel better and improve their heart function.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT05364866 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness and safety of cryoballoon ablation compared to antiarrhythmic drug therapy in patients diagnosed with atrial fibrillation and heart failure across different ejection fraction categories. Participants will be divided into two groups: one receiving cryoballoon catheter ablation and the other receiving medical therapy. The study aims to assess outcomes related to symptom relief and heart function. Eligible participants must be between 18 and 80 years old and provide informed consent.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic paroxysmal or persistent atrial fibrillation and heart failure.

Not a fit: Patients with a history of certain cardiac treatments or conditions, such as previous ablation or cardiac surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with atrial fibrillation and heart failure.

How similar studies have performed: While there have been studies on atrial fibrillation treatments, the specific comparison of cryoballoon ablation versus medical therapy in this patient population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
* At least 18 years old and not older than 80 years old.
* Able and willing to give informed consent.

Exclusion Criteria:

* History of AF treatment with class I or III AAD, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
* Previous left atrial ablation.
* Previous cardiac surgery including prosthetic valves.
* Permanent pacemaker or defibrillator implant.
* Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
* History of previous myocardial infarction or percutaneous intervention during the last 3 months.
* Any history of previous transient ischemic attack, prolonged reversible ischemic neurological deficit, and/or stroke.
* Known intracardiac thrombus formation.
* Pulmonary vein stent.
* Known cryoglobulinaemia.
* Active systemic infection.
* Hypertrophic cardiomyopathy.
* Life expectancy is ≤1 year.
* Reversible cause of atrial fibrillation (eg, hyperthyroidism or alcoholism).
* Abnormal long or short QT intervals, signs of Brugada syndrome, known family history of inherited ion channel disease, and/or arrhythmogenic right ventricular dysplasia.
* Chronic obstructive pulmonary disease with detected pulmonary hypertension and/or any other evidence of significant lung disease.
* Contraindication for oral anticoagulation.
* Pregnant women or woman of childbearing potential with inadequate birth control.
* Women who are breastfeeding.
* Any significant congenital heart defect corrected or not corrected; however, patent foramen ovale is allowed.
* Thrombocytosis (platelet count \> 600,000/μL) or thrombocytopenia (platelet count \< 100,000/μL).
* Untreated or uncontrolled hyperthyroidism or hypothyroidism.
* Renal dysfunction with glomerular filtration rate \< 60 mL/min.
* Unstable angina pectoris.
* Symptomatic carotid stenosis.
* Myxoma based on laboratory abnormalities.
* Sarcoidosis.
* Unwilling to unable to comply with the study procedure and follow-up schedule due to any disease condition.
* Legal incapacity or evidence that the patient cannot understand the purpose and risks of the study, including inability to comply fully with study procedures and follow-up.
* Employed by Medtronic, or the department of an investigator, or close-familial relative of an investigator.
* Enrolled or planning to participate in a potentially confounding drug or device trial during this study.

Where this trial is running

Nantong, Jiangsu

• Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qi Lu, MD

Conditions Cardiovascular Diseases