Personalized ablation treatment for persistent atrial fibrillation

Patient-TAILORed Ablation of Atrial Fibrillation Drivers in Persistent Stages Based on Instantaneous Amplitude and Frequency Modulation Criteria (TAILOR-AF)

This study is testing a new personalized treatment for patients with persistent atrial fibrillation to see if it can improve their heart rhythm by targeting specific areas causing the problem.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hospital San Carlos, Madrid (Academic / other)
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT05169320 on ClinicalTrials.gov

What this trial studies

This observational study focuses on improving outcomes for patients with persistent atrial fibrillation (AF) by utilizing a novel mapping strategy to identify the specific regions responsible for maintaining AF. The approach involves the use of a conventional electroanatomical mapping system combined with advanced algorithms that analyze atrial signals to locate leading drivers of AF. Patients who have not responded to previous pulmonary vein isolation procedures will be monitored and treated using this tailored ablation strategy. The study aims to enhance the effectiveness of catheter-based ablation techniques in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with symptomatic persistent atrial fibrillation who have undergone at least two previous pulmonary vein isolation procedures.

Not a fit: Patients with paroxysmal atrial fibrillation or those for whom sinus rhythm restoration is not a treatment goal may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce recurrence rates of atrial fibrillation in patients who have not benefited from standard treatments.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for persistent atrial fibrillation, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients with symptomatic persistent AF (defined as a sustained episode lasting ≥ 7 days) despite ≥2 previous PVI, with or without other atrial anatomical targets isolated in previous procedures (e.g. superior vena cava, coronary sinus or others).
2. AF episodes refractory to ≥1 antiarrhythmic drug (flecainide, propofenone, amiodarone or droneradore) or adverse events related to antiarrhythmic drugs that do not allow long-term drug therapy.
3. Age between 18-75 years old.
4. Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
5. Signed informed consent.
6. Confirmed pulmonary vein isolation in the index (in current protocol) procedure.

Exclusion Criteria:

1. Patients with paroxysmal AF (defined as a sustained episode lasting \< 7 days).
2. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued.
3. Patients with AF secondary to an obvious reversible cause.
4. Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
5. Non-sustained AF during the mapping procedure.
6. Severe underlying systemic disease (e.g. dementia, any end-disease stage, sepsis, etc).
7. Severe left atrial dilation (left atrial volume \>73 ml/m2).
8. Severe underlying cardiac disease (e.g. left ventricular ejection fraction ≤35%, severe non-corrected valvular disease, severe non-corrected coronary artery disease, hypertrophic cardiomyopathy, other inherited arrhythmia syndromes, severe dilated cardiomyopathy with NYHA functional class III, IV).
9. Hemodynamic instability due to any cardiac or non-cardiac disease.
10. Pregnancy.

Where this trial is running

Madrid and 1 other locations

• Centro Nacional de Investigaciones Cardiovasculares (CNIC) — Madrid, Spain (Active_not_recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: David Filgueiras-Rama, MD, PhD — Hospital Clínico San Carlos & CNIC
• Study coordinator: David Filgueiras-Rama, MD, PhD

Conditions Persistent Atrial Fibrillation