Comparing two methods for treating persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of hybrid endo-epicardial partial left atrial isolation versus conventional endocardial catheter ablation in patients with persistent atrial fibrillation. The study is designed for patients who have not responded to at least one antiarrhythmic drug and seeks to determine which technique offers better outcomes in terms of rhythm control. By comparing these two approaches, the trial hopes to provide insights into the most effective treatment for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients between the ages of 18 and 75, both inclusive, at the time of the consent date.
2. Patients with persistent atrial fibrillation refractory to at least one antiarrhythmic drug (Class I or III).
3. Signature of written informed consent.

Exclusion Criteria:

1. Continuous Persistent atrial fibrillation of more than 4 years.
2. Moderate to severe valvular heart disease.
3. Severe atrial dilatation (left appendage AP diameter \> 55 mm or \> 50ml/m2).
4. Patients requiring concomitant cardiac surgery or with previous cardiac surgery.
5. Left ventricular ejection fraction \<40%.
6. History of pericarditis.
7. Previous stroke.
8. Presence of active infection or sepsis, esophageal ulcer stricture and/or esophageal varices.
9. Patients with renal dysfunction defined as GFR less than or equal to 40 ml/min/m2.
10. Contraindication for chronic anticoagulation.
11. Patients who have undergone prior left atrial catheter ablation for atrial fibrillation or who are receiving treatment for ventricular arrhythmia.
12. Patients with severe chronic obstructive pulmonary disease considered GOLD III.
13. Patients with active neoproliferative disease or other concomitant disease where the medical team considers that ablation places the patient at unacceptable risk.
14. Pregnant, lactating women.
15. Patients who have previously presented allergic reactions to gadolinium.
16. Patients with claustrophobia that makes it impossible to perform nuclear magnetic resonance.
17. Persistent AF \< 3 months

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Manuel Castellà, MD PhD
• Email: mcaste@clinic.cat
• Phone: +34932275515

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a new catheter for treating persistent atrial fibrillation

  This study is testing a new catheter to see if it can safely help people with persistent atrial fibrillation who haven't found relief from other treatments.

  Recruiting at 4 sites Boston Scientific Corporation · Brussels and 3 other locations · NCT06510556

• Hybrid ablation for treating persistent atrial fibrillation

  This study is testing a new hybrid treatment for people with persistent atrial fibrillation to see if it works better than the standard catheter procedure in helping them stay free from heart rhythm problems.

  Recruiting at 5 sites St. George's Hospital, London · Chertsey and 6 other locations · NCT05411614

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.