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Tests treatment safety and results for Persistent Atrial Fibrillation Longstanding
Official title Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PFA+ADM) Pilot Study. Development of an Ablation Strategy to Improve the Efficacy of Long Standing Atrial Fibrillation Ablation in Patients With High Comorbidity Burden or Heart Failure
ClinicalTrials.gov ID: NCT07118488
What this study is testing
- What it's testing
- To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age between 18 and 80.
- Ability and willingness to follow the study protocol, including informed consent.
- Symptomatic long-standing AF for at least one month, documented by ECG or dual-chamber device recordings.
- History of failure, intolerance, or refusal of antiarrhythmic drug therapy.
- New York Heart Association (NYHA) functional class II or III, or left ventricular dysfunction (LVEF ≤ 50%) or a CHA2DS2-VASc score of 4 or more.
You likely can't join if
- Left atrial diameter \>5.5 cm.
- Previous left atrial ablation or surgery.
- Lack of anticoagulation therapy for 3 weeks prior to the procedure.
- Pulmonary vein stents or stenosis.
- Pre-existing diaphragmatic paralysis.
- Cardiac valve prosthesis or significant valve disease.
See the full eligibility criteria
- Age between 18 and 80.
- Ability and willingness to follow the study protocol, including informed consent.
- Symptomatic long-standing AF for at least one month, documented by ECG or dual-chamber device recordings.
- History of failure, intolerance, or refusal of antiarrhythmic drug therapy.
- New York Heart Association (NYHA) functional class II or III, or left ventricular dysfunction (LVEF ≤ 50%) or a CHA2DS2-VASc score of 4 or more.
- Optimal medical treatment for heart failure for at least three months for patients with left ventricular dysfunction.
- Left atrial diameter \>5.5 cm.
- Previous left atrial ablation or surgery.
- Lack of anticoagulation therapy for 3 weeks prior to the procedure.
- Pulmonary vein stents or stenosis.
- Pre-existing diaphragmatic paralysis.
- Cardiac valve prosthesis or significant valve disease.
- Recent cardiac surgery or interventions within the past 3 months.
- Unstable angina, NYHA Class IV heart failure.
- Pulmonary hypertension or rheumatic heart disease.
- Blood clotting disorders.
- Contraindications to chronic anticoagulation.
- Active infection or hypertrophic cardiomyopathy.
- Reversible causes of AF, such as hyperthyroidism or sleep apnea.
- Stroke or TIA in the past 6 months.
- History of thromboembolic events or evidence of intracardiac thrombus.
- Women of childbearing age
- Life expectancy less than 12 months.
- Participation in another clinical trial.
- Allergy to adhesives.
- Inability to comply with study procedures.
- Inability to provide personal consent.
- NYHA Class IV heart failure.
- Left ventricular ejection fraction ≤ 25%.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.