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Pulsed Field Ablation for Atrial Fibrillation (PARALELL Trial)
PARALELL Trial Summary
This trialis testing a new medical device to safely treat PsAF.
PARALELL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPARALELL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PARALELL Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Pulsed Field Ablation (PFA) group
- Group 2: Pulsed Field CryoAblation (PFCA) group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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