First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

Launched by REGION ÖREBRO COUNTY · Jul 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called cryoablation compared to medication for patients with persistent atrial fibrillation (AF), which is a condition where the heart beats irregularly. The main goal is to see if cryoablation can help patients feel better and have fewer episodes of AF after 12 months. Participants will be randomly assigned to receive either cryoablation or antiarrhythmic drugs, and their progress will be monitored over three years using heart monitors and regular check-ups. Researchers want to find out if cryoablation not only reduces AF episodes but also improves overall quality of life and has fewer side effects.

To be eligible for this trial, participants should be between 65 and 75 years old and have experienced at least two episodes of symptomatic persistent AF in the last two years. They shouldn’t have severe heart issues or other significant medical conditions that could complicate treatment. Throughout the study, participants will undergo regular heart monitoring, complete questionnaires about their quality of life, and receive assessments of their heart health. This trial is not yet recruiting, but it aims to provide valuable insights into the best ways to treat persistent AF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months, the latest episode within the previous 6 months and one documented on a 12 lead ECG or Holter monitor, that is classified as either
• • 1. Classical persistent AF (continuously sustained beyond 7 days and \<12 months in duration) as defined by ESC guidelines14 OR
• • 2. Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion to sinus rhythm is lacking during the past 24 months).
• • Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF.
• Exclusion Criteria:
• • 1. Regular daily use of AAD class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted).
• • 2. Previous AF ablation or surgery.
• • 3. Severe heart failure (NYHA III-IV).
• • 4. Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm).
• • 5. Hypertrophic cardiomyopathy (septal or posterior wall thickness \>1.5 cm)
• • 6. Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) \> 48.
• • 7. Significant valvular disease requiring treatment or valve prothesis.
• • 8. Severe Chronic Obstructive Pulmonary Disease (COPD) stage III or chronic kidney disease (eGFR\< 30 umol/l)).
• • 9. Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
• • 10. Myocardial infarction, revascularisation previous 6 months.
• • 11. Stroke or Transient Ischemic Attack (TIA) within previous 6 months.
• • 12. Tachycardiomyopathy.
• • 13. Dependent on VVI (ventricular single chamber inhibited) pacing.
• • 14. Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
• • 15. Expected survival less than 3 years, alcohol or drug abuse.
• • 16. Participation in another trial or absence of consent.