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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreAwards & 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very high body mass index (BMI).I am between 18 and 80 years old.I am willing and able to give my consent for treatment.I have severe sleep apnea not treated with a machine.I have not had a stroke or TIA in the past year.I have a history of blood clotting or bleeding disorders.I am scheduled for a procedure to treat my persistent atrial fibrillation that has lasted more than 7 days.I am willing and able to follow the study's requirements.I have a history of cryoglobulinemia.You have a mental illness, addictive disease, or a terminal illness with a life expectancy of less than two years. You are also expected to be away from the research center for a long time and may not be able to follow the study rules.I have had or currently have paralysis of one side of my diaphragm.I have a heart condition that did not improve with at least one type of medication.I have had atrial fibrillation for more than a year.I have significant heart issues, including a low heart pump function or recent serious heart procedures.I have had a procedure to correct an irregular heartbeat.My atrial fibrillation is due to an imbalance in body salts, thyroid issues, or another reversible cause.I have severe COPD and have used steroids in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed Field Ablation (PFA) group
- Group 2: Pulsed Field CryoAblation (PFCA) group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.