Using the iCLAS Cryoablation System to treat Atrial Fibrillation
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
This study is testing a new cryoablation device to see if it can safely help people with hard-to-treat atrial fibrillation and atrial flutter feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adagio Medical Industry-sponsored |
| Locations | 4 sites (Aalst and 3 other locations) |
| Trial ID | NCT05416086 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, single-arm, multi-center investigation aimed at gathering real-world safety and performance data for the Adagio Medical iCLAS Cryoablation System. It focuses on patients with drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, and Atrial Flutter. Participants will undergo a cryoablation procedure, and the study will monitor outcomes to assess the effectiveness and safety of the device in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing recurrent, symptomatic Atrial Fibrillation and are scheduled for an ablation procedure.
Not a fit: Patients with contraindications to the iCLAS Cryoablation System or those with conditions that make them poor candidates for the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from recurrent Atrial Fibrillation and related conditions.
How similar studies have performed: Other studies have shown success with similar cryoablation approaches, indicating potential for positive outcomes in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is ≥ 18 years of age * Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System * Subject willing to comply with study requirements and give informed consent. Exclusion Criteria: * In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU). * Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor. * Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
Where this trial is running
Aalst and 3 other locations
- Onze-Lieve-Vrouw Hospital Aalst (OLV) — Aalst, Belgium (Recruiting)
- Universitatsklinikum Erlangen — Erlangen, Germany (Recruiting)
- St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nabil M Jubran
- Email: njubran@adagiomedical.com
- Phone: (949) 348-1188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.