Clinical trial NCT05408754: Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
Official title: PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Pulsed Field Ablation
Pulsed Field CryoAblation
Persistent AF
PFA
PFCA
AF
Adagio Medical
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Primary Endpoint for Safety
timeFrame: Up to 7 days following the ablation procedure
measure: Primary Procedural Performance Outcome
timeFrame: Procedure
Secondary outcomes:
measure: One-Year Safety
timeFrame: 12 months
measure: One-Year Performance
timeFrame: 12 months
measure: Procedural Performance - ablation time
timeFrame: procedure
measure: Procedural Performance - procedure time
timeFrame: procedure
measure: Procedural Performance - fluoroscopy time
timeFrame: procedure
measure: Procedural Performance - intraprocedural PV reconnection rate
timeFrame: procedure
measure: Procedural Performance - AAD use
timeFrame: procedure and up to 12-month
measure: Procedural Performance - repeat ablation
timeFrame: procedure and up to 12-month
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis (OLV)
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
state: Quebec
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Dublin
country: Ireland
facility: Blackrock Health
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: London
country: United Kingdom
facility: St George'S University Hospital
Study officials:
affiliation: McGill University Health Centre; Montreal, Canada
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
References: