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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PARALELL Trial 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.Check my eligibility
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.See study design
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.

PARALELL Trial Eligibility Criteria

Inclusion Criteria

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

PARALELL Trial 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

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

PARALELL 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
6 Previous Clinical Trials
531 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research limited to those above a certain age?

"According to the stipulations of this clinical trial, patients have to be aged between 18 and 80. Those beneath 18 can register for 11 separate trials while those over 65 may participate in 478 different studies."

Answered by AI

How many individuals are currently enrolled in this clinical experiment?

"Affirmative, the information on clinicaltrials.gov suggests that this experiment is actively recruiting candidates. This research was initially posted online on October 20th 2022 and has been adjusted most recently on December 13th 2022. Altogether 78 participants are needed at a single site for its successful completion."

Answered by AI

Are there presently any openings for volunteers to join this research effort?

"Affirmative. According to clinicaltrials.gov, this research is still recruiting participants having initially been posted on October 20th 2022 and most recently updated on December 13th 2022. 78 individuals are required from one location."

Answered by AI

What is the primary purpose of this medical experiment?

"According to the trial sponsor, Adagio Medical, the primary outcome measured in this study is 'Primary Procedural Performance Outcome' over a period of 7 days. In addition to this metric, secondary outcomes such as 'One-Year Performance', 'Procedure Time', and 'Intraprocedural PV Reconnection Rate' are also being monitored."

Answered by AI

To whom is participation in this trial available?

"This clinical trial is searching for 78 individuals, aged between 18 and 80 years old, who have been diagnosed with atrial fibrillation. To be eligible for this study, volunteers must meet the following criteria: (1) Male or female of legal age; (2) Resistant to Class I or III AADs; (3) Willingness and capacity to provide informed consent; (4) Commitment to complete all baseline evaluations over the course of the research project; and (5) Having undergone a recent ablation of persistent (> 7 days), symptomatic AF as revealed by ECG recordings or Holter monitoring."

Answered by AI
~17 spots leftby Oct 2024