Atrial FibrillationNCT05416086
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
A study testing cryoablation procedure using the iCLAS Cryoablation System in people with Atrial Fibrillation and Atrial Flutter, run by Adagio Medical at 4 sites in 3 countries.
Trial summary
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation
- What is being tested?
- cryoablation procedure using the iCLAS Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Sep 2021to 28 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435
Erasmus MC
Rotterdam
About this study
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
Read the detailed description
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Being tested
- cryoablation procedure using the iCLAS Cryoablation System
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablation procedure using the iCLAS Cryoablation SystemDevice
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
| Study group | Role | What they receive |
|---|---|---|
| iCLAS Cryoablation arm | Other | all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month Receives: Device: cryoablation procedure using the iCLAS Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome - freedom from AF
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
Measured: 12 months
Primary outcome - freedom from AF/AT/AFL
Freedom from Atrial Arrhythmia at 12-months
Measured: 12 months
Primary outcome - freedom from Device/Procedure Related Adverse Events
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Measured: during procedure and up to 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start3 Sep 2021
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Why it stopped: Adagio Medical no longer manufactures the iCLAS Cryoablation System
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adagio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416086
- Sponsor's protocol ID
- CS-086
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abeln BGS, Addeo L, De Potter T, Boersma LVA. Durability of Ultra-Low Temperature Cryoablation Lesions in Atrial Fibrillation: Insights From Repeat Ablation Procedures. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1264-1271. doi: 10.1111/jce.16665. Epub 2025 Mar 27.
PubMed 40150915
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
- ClinicalTrials.gov ID
- NCT05416086
- Acronym / sponsor ID
- CS-086
- Conditions
- Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adagio Medical no longer manufactures the iCLAS Cryoablation System
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
Detailed description
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCLAS Cryoablation arm | Other | Device: cryoablation procedure using the iCLAS Cryoablation Systemall subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoablation procedure using the iCLAS Cryoablation Systemall subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon | Device | iCLAS Cryoablation arm |
Primary outcome
Primary outcome - freedom from AF
Time frame: 12 months
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
Primary outcome - freedom from AF/AT/AFL
Time frame: 12 months
Freedom from Atrial Arrhythmia at 12-months
Primary outcome - freedom from Device/Procedure Related Adverse Events
Time frame: during procedure and up to 12-month follow up
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Results and safety
The study was stopped early (reason given: Adagio Medical no longer manufactures the iCLAS Cryoablation System). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 40150915Abeln BGS, Addeo L, De Potter T, Boersma LVA. Durability of Ultra-Low Temperature Cryoablation Lesions in Atrial Fibrillation: Insights From Repeat Ablation Procedures. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1264-1271. doi: 10.1111/jce.16665. Epub 2025 Mar 27.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation procedure using the iCLAS Cryoablation System in people with Atrial Fibrillation and Atrial Flutter, run by Adagio Medical at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Adagio Medical no longer manufactures the iCLAS Cryoablation System). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome - freedom from AF (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.