Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

NCT ID: NCT05408754

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2025-05-01

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.

Detailed Description

Enrolled subjects will be treated (ablation) with the Adagio PFA or PFCA System in a 1:1 randomized fashion.

Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI), and CTI at the discretion and clinical judgment of the investigator.

Data will be collected throughout 12-month follow up period to assess safety and performance of the device. Recurrence of atrial arrhythmias is measured by 12-lead ECGs and 48-hour continuous ECG recording (Holter).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed Field Ablation (PFA) group

PsAF patients treated by PFA

Group Type: EXPERIMENTAL

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

Intervention Type: 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 CryoAblation (PFCA) group

PsAF patients treated by PFCA

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adagio Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre; Montreal, Canada

Locations

Onze-Lieve-Vrouwziekenhuis (OLV)

Aalst, , Belgium

Site Status: RECRUITING

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

Montreal, Quebec, Canada

Site Status: RECRUITING

Nemocnice Na Homolce

Prague, , Czechia

Site Status: RECRUITING

Blackrock Health

Dublin, , Ireland

Site Status: RECRUITING

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status: RECRUITING

St George'S University Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

Belgium; Canada; Czechia; Ireland; Netherlands; United Kingdom

Central Contacts

Nabil Jubran

Role: CONTACT

njubran@adagiomedical.com

9493481188

Doug Kurschinski

Role: CONTACT

dkurschinski@adagiomedical.com

9493481188

Facility Contacts

Tom De Potter, M.D.

Role: primary

tom.de.potter@olvz-aalst.be

Atul Verma, MD

Role: primary

Petr Neuzil, M.D.

Role: primary

petr.neuzil@homolka.cz

David Keane, M.D.

Role: primary

dkeane@svhg.ie

Lucas Boersma, Prof

Role: primary

Mark Gallagher, M.D.

Role: primary

mark.gallagher@stgeorges.nhs.uk

Other Identifiers

CS-169

Identifier Type: -

Identifier Source: org_study_id