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Atrial Ablation

Pulsed Field Ablation for Atrial Fibrillation (PARALELL Trial)

N/A
Recruiting
Led By Atul Verma, MD
Research Sponsored by Adagio Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness and ability to give an informed consent
Be older than 18 years old
Must not have
History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device
Stroke or TIA within the last year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trialis testing a new medical device to safely treat PsAF.

Who is the study for?
This trial is for adults aged 18-80 with symptomatic, drug-resistant persistent atrial fibrillation (lasting over 7 days but less than a year). Participants must be scheduled for an ablation procedure and have failed at least one antiarrhythmic drug. Exclusions include severe heart conditions, previous ablations or cardiac surgeries, clotting disorders, extreme obesity (BMI > 40), and other health issues that could affect the study.
What is being tested?
The study compares two systems: Adagio PFA and PFCA in treating persistent atrial fibrillation. It's a first-in-human trial to assess safety and performance of these new ablation technologies. Patients will be randomly assigned to either treatment arm in multiple centers.
What are the potential side effects?
Potential side effects may include complications from the ablation such as bleeding or infection at the site of catheter insertion, damage to heart tissue or blood vessels, adverse reactions to anesthesia used during the procedure, thromboembolic events like stroke, and arrhythmias.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to give my consent for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe sleep apnea not treated with a machine.
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I have not had a stroke or TIA in the past year.
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I have a history of blood clotting or bleeding disorders.
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I have had atrial fibrillation for more than a year.
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I have had or currently have paralysis of one side of my diaphragm.
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I have significant heart issues, including a low heart pump function or recent serious heart procedures.
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I have had a procedure to correct an irregular heartbeat.
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I have severe COPD and have used steroids in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Endpoint for Safety
Primary Procedural Performance Outcome
Secondary study objectives
One-Year Performance
One-Year Safety
Procedural Performance - AAD use
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pulsed Field CryoAblation (PFCA) groupExperimental Treatment1 Intervention
PsAF patients treated by PFCA
Group II: Pulsed Field Ablation (PFA) groupExperimental Treatment1 Intervention
PsAF patients treated by PFA

Find a Location

Who is running the clinical trial?

Adagio MedicalLead Sponsor
7 Previous Clinical Trials
847 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
430 Patients Enrolled for Atrial Fibrillation
Atul Verma, MDPrincipal InvestigatorMcGill University Health Centre; Montreal, Canada
12 Previous Clinical Trials
3,014 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,989 Patients Enrolled for Atrial Fibrillation

Media Library

Adagio PFA and PFCA Systems (Atrial Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT05408754 — N/A
Atrial Fibrillation Research Study Groups: Pulsed Field Ablation (PFA) group, Pulsed Field CryoAblation (PFCA) group
Atrial Fibrillation Clinical Trial 2023: Adagio PFA and PFCA Systems Highlights & Side Effects. Trial Name: NCT05408754 — N/A
Adagio PFA and PFCA Systems (Atrial Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408754 — N/A
~26 spots leftby Nov 2025
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