Status:
ACTIVE_NOT_RECRUITING
Radial Ablation for the Control of Persistent Atrial Fibrillation
Lead Sponsor:
Fundacion para la Innovacion en Biomedicina (FIBMED)
Collaborating Sponsors:
Hospital General Universitario Gregorio Marañon
Hospital Universitario 12 de Octubre
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating ...
Detailed Description
Atrial fibrillation is the most common arrhythmia in clinical practice, and its treatment still remains suboptimal. Electrical isolation of the pulmonary veins with radiofrequency ablation or cryoabla...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and ≤ 75 years.
- Non-valvular symptomatic persistent atrial fibrillation.
- Patient willingness to participate in the study providing signed written informed consent.
- Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment.
- Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment.
Exclusion
- Left atrial diameter \> 5.5 cm in the last echocardiogram.
- Contraindication of chronic anticoagulation or heparin.
- Previous atrial fibrillation ablation procedure.
- Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement.
- Previous diagnosis for hyperthyroidism or hypothyroidism.
- Mental or physical illness that disables the patient to participate in the study.
- Scheduled cardiac percutaneous or surgical intervention.
- Non-controlled hypertension \> 160/100.
- Terminal renal insufficiency or dialysis.
- Functional class IV of the New York Heart Association (NYHA).
- Moderate valvular disease or previous mitral prosthesis.
- Previous hypertrophic heart disease.
- Life expectancy less than 12 months.
- Inclusion on the transplant list.
- Participation in another study so as not to interfere with the results.
- Previous atrioventricular block.
- Pericardial effusion.
- Pregnancy or childbearing age without contraceptive treatment.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04662489
Start Date
March 1 2022
End Date
February 1 2026
Last Update
March 12 2025
Active Locations (3)
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1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28009
2
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
3
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222