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Status:

UNKNOWN

Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

Lead Sponsor:

Adagio Medical

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18-80 years

Phase:

NA

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 Sys...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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
  • Unstable angina or ongoing myocardial ischemia
  • Myocardial infarction within the previous six (6) months prior to procedure
  • Moderate or severe mitral insufficiency or stenosis based on most recent TTE
  • Atrial myxoma
  • 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

Key Trial Info

Start Date :

October 20 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2025

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT05408754

Start Date

October 20 2022

End Date

May 1 2025

Last Update

April 24 2024

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

Onze-Lieve-Vrouwziekenhuis (OLV)

Aalst, Belgium, B-9300

2

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

Montreal, Quebec, Canada, H3G 1A4

3

Nemocnice Na Homolce

Prague, Czechia, 150 30

4

Blackrock Health

Dublin, Ireland, A94 E4X7