New treatment for persistent atrial fibrillation using pulsed electric field energy

Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

This study is testing a new way to treat persistent atrial fibrillation using pulsed electric field energy to see if it works better and is safer than traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 9 sites (Graz and 8 other locations)
• Trial ID: NCT05418725 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of pulsed electric field (PEF) energy for the ablation of persistent atrial fibrillation (AF). The study aims to achieve durable pulmonary vein isolation (PVI) by creating permanent lesions in cardiac tissue without the thermal damage associated with traditional ablation methods. Participants will be randomized to receive either PEF-based ablation or conventional catheter ablation techniques. The trial will assess outcomes related to AF recurrence and complications over a specified follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with drug-resistant symptomatic persistent atrial fibrillation.

Not a fit: Patients with non-persistent atrial fibrillation or those who have not failed antiarrhythmic drug treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients with persistent atrial fibrillation.

How similar studies have performed: While the use of pulsed electric field energy in cardiac ablation is a novel approach, similar studies have shown promising results in other areas of medicine.

Eligibility criteria

Inclusion Criteria:

1. Patients with drug-resistant symptomatic persistent AF meeting all the following criteria:

   1. Persistent: continuous drug resistant AF that is sustained beyond 7 days (but less than 1 year).
   2. Frequency: At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 6 months of enrolment.
   3. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
3. Patient who are willing and capable of:

   1. Providing informed consent to undergo study procedures AND
   2. Participating in all examinations and follow-up visits and tests associated with this clinical study.
   3. Patient having a smart phone compatible with the Event Monitor device.
4. Highly effective contraception for women of childbearing potential.
5. Effective oral anticoagulation \>3 weeks prior to planned ablation procedure
6. Patient affiliated to or beneficiary of national health security scheme for French participants.

Exclusion Criteria:

* 1. AF that is any of the following:

  1. Paroxysmal AF by diagnosis or that terminates spontaneously within 7 days of onset
  2. Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:

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  1. Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
  2. Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
  3. Any prior atrial surgery
  4. Intra-atrial septal patch or interatrial shunt
  5. Atrial myxoma
  6. Current LA thrombus
  7. LA appendage closure, device or occlusion, past or anticipated
  8. Any PV abnormality, stenosis or stenting (common and middle PVs are admissible) 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:

  a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area \< 1.5cm or gradient \> 20 mm Hg iv. Mitral stenosis: if already characterized, valve area \< 1.5cm or gradient \> 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following procedures, implants or conditions:

  a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Left ventricular ejection fraction (LVEF) \< 40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two BP measurements at baseline assessment) v. Symptomatic resting bradycardia vi. Implantable loop recorder or insertable cardiac monitor, b. Within the 3 months preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Pericarditis or symptomatic pericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months preceding the Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder of blood clotting or bleeding diathesis 6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivity to contrast media not controllable by premedication 9. Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period 10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
  1. Body Mass Index (BMI) \> 40.0
  2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
  3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  4. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
  5. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
  6. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
  7. Active systemic infection
  8. COVID-19 disease
  9. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date.

  i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c \> 8.0% if test result already obtained), untreated obstructive sleep apnea or active alcohol abuse j. Predicted life expectancy less than one (1) year 11. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements/ Patient under legal protection 12. Current or anticipated enrollment in any other clinical study. 13. Employees / family members of:
  1. FARAPULSE or any of its affiliates or contractors
  2. The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed.

Where this trial is running

Graz and 8 other locations

• Medical University of Graz — Graz, Austria (Not_yet_recruiting)
• AZ Sint-Jan Brugge-Oostende — Bruges, Belgium (Not_yet_recruiting)
• Homolka Hospital — Prague, Czechia (Not_yet_recruiting)
• Institute for Clinical and Experimental Medicine — Prague, Czechia (Not_yet_recruiting)
• CHU Bordeaux — Pessac, France (Recruiting)
• CHU Toulouse — Toulouse, France (Not_yet_recruiting)
• Clinique Pasteur, Toulouse — Toulouse, France (Not_yet_recruiting)
• Cardiovascular Center Bad Neustadt — Bad Neustadt an der Saale, Germany (Not_yet_recruiting)
• Deutsches Herzzentrum München — Munich, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Pierre Jais, MD, PhD

Conditions Atrial Fibrillation; Persistent Atrial Fibrillation; Cardiac Arrhythmia; Pulmonary vein Isolation; Catheter Ablation; RF Ablation; Pulsed Field Energy; Linear lesion