Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

NCT05408754 | Completed DMC

• 1 other identifier: CS-169
• Study Type: interventional
• Target: 89
• Locations: 6 countries
• Sites: 6

Brief Summary

A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.

Conditions

Atrial Fibrillation

Keywords

Pulsed Field Ablation; Pulsed Field CryoAblation; Persistent AF; PFA; PFCA; AF; Adagio Medical

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint for Safety

  Analysis of the proportion of subjects who are free from device/procedure-related Major Adverse Events that occur during or following the ablation procedure

  Up to 7 days following the ablation procedure

• Primary Procedural Performance Outcome

  Analysis of the evidence of procedural electrical isolation of all pulmonary veins, posterior wall, and bidirectional block (if applicable) across all other ablation lines using the study device.

  Procedure

Secondary Outcomes (8)

• One-Year Safety

  12 months

• One-Year Performance

  12 months

• Procedural Performance - ablation time

  procedure

• Procedural Performance - procedure time

  procedure

• Procedural Performance - fluoroscopy time

  procedure

Study Arms (2)

Pulsed Field Ablation (PFA) group

EXPERIMENTAL

PsAF patients treated by PFA

Device: Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.

Pulsed Field CryoAblation (PFCA) group

EXPERIMENTAL

PsAF patients treated by PFCA

Device: Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.

Interventions

Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF. DEVICE

Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI). A right atrial cavo-tricuspid line for bi-directional block may be performed at discretion and clinical judgment of the investigator

Pulsed Field Ablation (PFA) group; Pulsed Field CryoAblation (PFCA) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE
• Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening
• NYHA Class III or IV heart failure documented within the previous 12-months
• An implanted pacemaker or ICD
• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
• Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
• Interatrial baffle, closure device, patch, or PFO occluder
• Presence of a left atrial appendage occlusion device
• Presence of any pulmonary vein stenting devices
• Coronary artery bypass graft (CABG) or PTCA procedure within six (6) months prior to procedure

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (6)

Onze-Lieve-Vrouwziekenhuis (OLV)

Aalst, B-9300, Belgium

Location

McGill University Health Centre (MUHC), Montreal General Hospital (MGH)

Montreal, Quebec, H3G 1A4, Canada

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Blackrock Health

Dublin, A94 E4X7, Ireland

Location

St Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

St George'S University Hospital

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Verma, MD

  McGill University Health Centre; Montreal, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: October 20, 2022
• Primary Completion: October 14, 2024
• Study Completion: March 3, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); IE (1); BE (1); NL (1); GB (1); CZ (1)