Using pulsed field technology to treat persistent atrial fibrillation

PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

This study is testing two new treatments for people with persistent atrial fibrillation to see which one works better at stopping heart rhythm problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Adagio Medical (Industry-sponsored)
• Locations: 6 sites (Aalst and 5 other locations)
• Trial ID: NCT05408754 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, two-arm, multi-center, randomized, open-label study designed to evaluate the safety and performance of the Adagio Pulsed Field Ablation (PFA) and Pulsed Field CryoAblation (PFCA) Systems in patients with persistent atrial fibrillation (PsAF). Participants will be randomly assigned to receive either PFA or PFCA treatment, which involves the isolation of pulmonary veins and other areas of the heart as determined by the investigator. Data will be collected over a 12-month follow-up period to assess the recurrence of atrial arrhythmias using ECG monitoring. The goal is to provide critical safety and efficacy data for these novel ablation techniques.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who are scheduled for ablation of symptomatic persistent atrial fibrillation and have not responded to at least one antiarrhythmic drug.

Not a fit: Patients with continuous atrial fibrillation lasting longer than 12 months or those with contraindications to ablation procedures will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from persistent atrial fibrillation who are refractory to standard medications.

How similar studies have performed: While this approach is novel, similar studies using pulsed field technology for cardiac ablation have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

IC 1 Male or female between the ages of 18 - 80 years

IC 2 Currently scheduled for an ablation of symptomatic persistent (\> 7 days) atrial fibrillation within the past year documented by ECG or Continuous Holter monitoring

IC 3 Refractory to at least one class I or III AAD. (Refractory defined as not effective or not tolerated)

IC 4 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study

IC 5 Willingness and ability to give an informed consent

Exclusion Criteria:

EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis

EC 2 Continuous AF lasting longer than 12-months

EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT

EC 4 AF secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause

EC 5 Structural heart disease as described below:

1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE
2. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening
3. NYHA Class III or IV heart failure documented within the previous 12-months
4. An implanted pacemaker or ICD
5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
7. Interatrial baffle, closure device, patch, or PFO occluder
8. Presence of a left atrial appendage occlusion device
9. Presence of any pulmonary vein stenting devices
10. Coronary artery bypass graft (CABG) or PTCA procedure within six (6) months prior to procedure
11. Unstable angina or ongoing myocardial ischemia
12. Myocardial infarction within the previous six (6) months prior to procedure
13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE
14. Atrial myxoma
15. Significant congenital anomaly

EC 6 BMI \> 40

EC 7 Any previous history of cryoglobulinemia (for those patients randomized to the PFCA arm)

EC 8 History of blood clotting or bleeding disease

EC 9 History of severe COPD requiring steroid use in the previous 12-months

EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device

EC 11 Stroke or TIA within the last year.

EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis

EC 13 Pregnant or lactating (current or anticipated during study follow-up

EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study

EC 15 Any other conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up

Where this trial is running

Aalst and 5 other locations

• Onze-Lieve-Vrouwziekenhuis (OLV) — Aalst, Belgium (Recruiting)
• McGill University Health Centre (MUHC), Montreal General Hospital (MGH) — Montréal, Quebec, Canada (Recruiting)
• Nemocnice Na Homolce — Prague, Czechia (Recruiting)
• Blackrock Health — Dublin, Ireland (Recruiting)
• St Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
• St George'S University Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Atul Verma, MD — McGill University Health Centre; Montreal, Canada
• Study coordinator: Nabil Jubran

Conditions Atrial Fibrillation; Pulsed Field Ablation; Pulsed Field CryoAblation; Persistent AF; PFA; PFCA; AF; Adagio Medical