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iCLAS™ for Atrial Fibrillation
Study Summary
This trial will evaluate a new device for treating atrial fibrillation, a common heart rhythm disorder. The device is minimally invasive and can be done in a doctor's office.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I cannot undergo atrial ablation, TEE, or take blood thinners due to health reasons.I have had cryoglobulinemia in the past.I am scheduled for a procedure to treat my persistent atrial fibrillation lasting more than 7 days but less than 12 months.I have severe sleep apnea not treated with a CPAP machine.I have had surgery or ablation for atrial fibrillation or flutter.I have had or currently have paralysis of one side of my diaphragm.I have severe COPD and have used steroids in the last year.I have had a stroke, TIA, or blood clot in the past year.I have tried a specific heart medication that didn't work, caused side effects, or wasn't preferred.I am willing and able to give my consent for treatment.I am willing and able to follow the study's requirements.I have a history of blood clotting or bleeding disorders.You have a very high body mass index (BMI), which may affect your eligibility for the study.My heart's pumping ability is reduced, or I have severe heart failure.I am between 18 and 80 years old.I have had atrial fibrillation continuously for over a year.My atrial fibrillation is due to an imbalance in body salts or thyroid issues.
- Group 1: iCLAS Ablation
- 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
Are there any Canadian locations where this research is being conducted?
"Subjects are being accepted at Mayo Clinic in Jacksonville, Grandview Medical Center located in Birmingham, and Prairie Heart Research Institute situated in Springfield. Additionally, 16 other clinics have been enlisted for this experiment."
Is this research open to participants aged 50 and above?
"This trial is open to all those aged 18 or above and below the age of eighty, in accordance with its accreditation regulations."
How many participants are currently being admitted to the experiment?
"Adagio Medical, the study's sponsor, requires 200 patients who meet the criteria to proceed with the trial. Two of their research sites are Mayo Clinic in Jacksonville and Grandview Medical Center in Birmingham."
What criteria must a person meet to participate in this experiment?
"This medical trial is recruiting 200 individuals, aged between 18 and 80 years old, who have been diagnosed with atrial fibrillation. To be eligible for the research project, participants must display a willingness to commit to pre-trial evaluations and assessments throughout the duration of the study as well as show that they are unresponsive to current antiarrhythmic drugs (Class I or III AADs). Further inclusion criteria require male or female volunteers falling within an age range of 18 - 80 years; having had continuous AF lasting greater than 7 days yet less than 12 months documented by either 24 hour Holter monitoring results from 180 days prior to"
Is recruitment for this clinical trial still ongoing?
"According to clinicaltrials.gov, this trial is actively searching for participants and was incepted on December 9th 2019 with its last edit taking place on February 14th 2022."
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