CompletedNot Applicable

Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance

Spain50 participantsStarted 2015-02

Plain-language summary

Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of rotors. The non-invasive identification of specific mechanism of AF maintenance in each patient could allow the selection of the most appropriate treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication. * Patients with persistent AF symptomatic and refractory to at least one antiarrhythmic medication. * Patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage D) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation. * Patients must be able and willing to provide written informed consent to participate in the study. * Prior anticoagulation for\> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal AF). Exclusion Criteria: * Patients with inadequate anticoagulation levels. * Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure. * Patients with moderate-to-severe mitral regurgitation. * Patients with contraindications to systemic anticoagulation with heparin or coumadin. * Prior atrial fibrillation ablation. * Patients who are or may potentially be pregnant. * Contraindication for adenosine administration; * Current enrollment in another investigational drug or device study. * Pacemaker or Implantable Cardioverter Defibrillator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.

Timeframe: 12 months post-first ablation procedure

Trial details

NCT IDNCT02497248

SponsorHospital General Universitario Gregorio Marañon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Atrial Fibrillation trials