NCT04662489Active, not recruiting
Radial Ablation for the Control of Persistent Atrial Fibrillation
Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para conTrol de la fibrilación Auricular persISTtente)
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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 the atrial fibrillation burden during one year follow-up.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 24 Nov 2020
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)
- Diseases
- Atrial fibrillation
- NCT number
- NCT04662489
What you commit to
- Study type: Interventional
- Planned participants: 244
- From 1 Mar 2022 to the primary completion date, 31 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Moderate valvular disease or previous mitral prosthesis.
- Previous hypertrophic heart disease.
- Inclusion on the transplant list.
- Previous atrioventricular block.
Other illness
- 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).
Age
- Pregnancy or childbearing age without contraceptive treatment.
Other
- Left atrial diameter \> 5.5 cm in the last echocardiogram.
- Contraindication of chronic anticoagulation or heparin.
- Life expectancy less than 12 months.
- Participation in another study so as not to interfere with the results.
- Pericardial effusion.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.