Persistent Atrial FibrillationNCT04061603
iCLAS™ for Persistent Atrial Fibrillation
A study testing Adagio AF Cryoablation System (iCLAS™) in people with Persistent Atrial Fibrillation, run by Adagio Medical at 21 sites in 4 countries.
Trial summary
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Adagio AF Cryoablation System (iCLAS™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 9 Dec 2019to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IC1 Male or female between the ages of 18 and 80 years
- IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained > 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF > 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
- IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
- IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
- IC5 Willingness and ability to give an informed consent
Who cannot join
- EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
- EC 2 Any duration of continuous AF lasting longer than 12-months
- EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- EC 5 Structural heart disease as described below:
- Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
Show all 31Show fewer
- Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening
- NYHA Class III or IV heart failure documented within the previous 12-months
- An implanted pacemaker or ICD
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
- Interatrial baffle, closure device, patch, or PFO occluder
- Presence of a left atrial appendage occlusion device
- Presence of any pulmonary vein stenting devices
- Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
- Unstable angina or ongoing myocardial ischemia
- Myocardial infarction within the previous six (6) months prior to procedure
- Moderate or severe mitral insufficiency or stenosis based on most recent TTE
- Atrial myxoma
- Significant congential anomaly
- EC 6 BMI > 40
- BMI >35 and no prior sponsor approval into the study
- EC 7 Any previous history of cryoglobulinemia
- EC 8 History of blood clotting or bleeding disease
- EC 9 History of severe COPD requiring steroid use in the previous 12-months
- EC 10 History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device
- EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
- EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis
- EC 13 Pregnant or lactating (current or anticipated during study follow-up)
- EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
- EC 15 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 two years, extensive travel away from the research center, COVID-19 related concerns)
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States16 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
Johns Hopkins University
Baltimore, Maryland, 21205
Grandview Medical Center
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio Health Research Institute
Columbus, Ohio, 43214
South Denver Cardiology Associates
Denver, Colorado, 80120
Northwestern University
Evanston, Illinois, 60208
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Banner Health
Phoenix, Arizona, 85006
The Valley Hospital
Ridgewood, New Jersey, 07450
University of California San Diego
San Diego, California, 92093
Prairie Heart Research Institute
Springfield, Illinois, 62701
Staten Island University Hospital - Northwell Health
Staten Island, New York, 10305
Netherlands2 sites
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein
Erasmus University Medical Center
Rotterdam, 3015 GD
About this study
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
Read the detailed description
A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Adagio AF Cryoablation System (iCLAS™)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adagio AF Cryoablation System (iCLAS™)Device
Endovascular ablation of the left and right atrium
| Study group | Role | What they receive |
|---|---|---|
| iCLAS Ablation | Experimental | Ablation of the left and right atrium with the Adagio Medical iCLAS System Receives: Device: Adagio AF Cryoablation System (iCLAS™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure
Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following:
- Death
- Myocardial infarction
- Cardiac perforation/pericardial tamponade
- Cerebral infarct or systemic embolism
- Major bleeding requiring transfusion of blood products
- Mitral or tricuspid valve damage
- Symptomatic pulmonary vein stenosis
- Severe (≥ 70%) pulmonary vein stenosis
- Permanent phrenic nerve injury
- Access site complications requiring pharmacological or surgical intervention
- Atrio-esophageal fistula
- Pericarditis
- Heart block requiring a permanent pacemaker
- Vagal nerve injury with GI dysmotility
- Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System
Measured: 12-months
Analysis of the Proportion of Subjects Receiving a Single Cryoablation Who Are Free From Any Documented Left Atrial Arrhythmia (AF/AFL/AT) Following the Blanking Period Lasting Longer Than 30 Seconds on a Continuous 24-hour ECG Recording (Holter Monitor).
Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) following the Blanking Period lasting longer than 30 seconds on a continuous 24-hour ECG recording (Holter monitor). The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
Measured: 12-months
Secondary outcomes (1)
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success
Percentage of patients with documentation of pulmonary vein isolation (LSPV, LIPV, RSPV, RIPV) and posterior wall isolation (PWI) and cavo-tricuspid isthmus (CTI) bidirectional block (BDB) following the last ablation of PV, PW, and CTI.
Measured: 20-minutes following last ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 Dec 2019
- Primary completion30 Aug 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent 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
- Model description
- Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adagio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suneet Mittal, MD, Principal investigator, Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061603
- Sponsor's protocol ID
- CS-200
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2019
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCLAS™ for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04061603
- Acronym / sponsor ID
- CS-200
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
Detailed description
A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation
| Arm | Type | Receives |
|---|---|---|
| iCLAS Ablation | Experimental | Device: Adagio AF Cryoablation System (iCLAS™)Ablation of the left and right atrium with the Adagio Medical iCLAS System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IC1 Male or female between the ages of 18 and 80 years
- IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained > 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF > 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
- IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
- IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
- IC5 Willingness and ability to give an informed consent
Key exclusion criteria (31 listed)
- EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
- EC 2 Any duration of continuous AF lasting longer than 12-months
- EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
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 |
|---|---|---|
| Adagio AF Cryoablation System (iCLAS™)Endovascular ablation of the left and right atrium | Device | iCLAS Ablation |
Primary outcome
Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure
Time frame: 12-months
Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System
Analysis of the Proportion of Subjects Receiving a Single Cryoablation Who Are Free From Any Documented Left Atrial Arrhythmia (AF/AFL/AT) Following the Blanking Period Lasting Longer Than 30 Seconds on a Continuous 24-hour ECG Recording (Holter Monitor).
Time frame: 12-months
Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) following the Blanking Period lasting longer than 30 seconds on a continuous 24-hour ECG recording (Holter monitor). The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
1 secondary outcome
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success
Time frame: 20-minutes following last ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Suneet Mittal, MD principal investigator
Valley Hospital
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adagio AF Cryoablation System (iCLAS™) in people with Persistent Atrial Fibrillation, run by Adagio Medical at 21 sites in 4 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 5 inclusion and 31 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: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Netherlands, Canada. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure (time frame: 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.