Atrial FibrillationCryoCure2NCT02839304
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
A study testing Cryoablation System in people with Atrial Fibrillation and Atrial Flutter, run by Adagio Medical at 3 sites in 3 countries.
Trial summary
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2016to 31 Mar 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with paroxysmal (PAF), persistent, or long standing persistent atrial fibrillation (PsAF) for which an ablation procedure was deemed most appropriate therapy. Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year.
- Reported incidence of at least one (1) documented episode of symptomatic atrial fibrillation (AF) during the twelve months preceding trial entry (should be documented by rhythm strip or ECG).
- Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation, or intolerable side effects due to AAD.
- Left atrial size <55 mm in largest dimension as measured and image documented by preoperative imaging (CT, MRI and/or TTE)
- Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure).
- Anticoagulation therapy: patient is receiving anticoagulation therapy four (4) weeks prior to the ablation procedure (where appropriate) according to 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation.
Show all 9Show fewer
- Patient is at least 18 and ≤80 years of age.
- Patient is able and willing to comply with mandatory pre and post follow-up testing.
- Patient is able and willing to give informed consent.
Who cannot join
- Patient had any previous left atrial ablation.
- History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
- Coronary artery bypass grafting (CABG) procedure within the last 3 months.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator.
- History of a documented thromboembolic event within the past one (1) year.
Show all 30Show fewer
- Diagnosed atrial myxoma.
- Patient has defibrillator implant.
- Patient has known cryoglobulinemia.
- Patient has any contraindication for oral anticoagulation.
- Anaphylactic allergy to contrast media.
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Acute illness or active systemic infection or sepsis.
- Unstable angina.
- Myocardial infarction within the previous three months.
- History of blood clotting or bleeding abnormalities.
- Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure.
- An intracardiac thrombus, tumor, or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access
- Patient has renal dysfunction with glomerular filtration rate < 30 ml/min/1.73m2.
- Structural heart disease of clinical significance including congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation.
- Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g. surgery, pericarditis).
- Any history of a cerebrovascular disease, including stroke or Transient Ischemic Attack.
- Patients with chronic obstructive pulmonary disease (COPD).
- Continued need for Amiodarone therapy post procedure.
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
- Any anatomical abnormality of the patient's esophagus which might interfere with esophageal warming balloon insertion, positioning or inflation.
- Enrollment in an investigational study evaluating another device or drug.
- Life expectancy less than 12 months.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- 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 SystemDevice
Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation Treatment | Experimental | Cryoablation System: Atrial Fibrillation Ablation Receives: Device: Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events.
Measured: 1 day
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events within 7 days of procedure
Measured: 7 days
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 7 days after the procedure
Measured: 30 days
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 30 days after the procedure
Measured: 12 months
Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block).
Measured: 1 day
Technical performance assessed by AF termination targeting driver regions, when applicable
Measured: 1 day
Technical performance assessed by complete linear block of linear lesions if deployed
Measured: 1 day
Secondary outcomes (5)
Performance assessed by percentage of RF focal ablation (touch up) to reach the primary performance endpoint.
Measured: 1 day
Performance assessed by procedural fluoroscopy times
Measured: 1 day
Performance assessed by ablation times
Measured: 1 day
Performance assessed by total procedure times)
Measured: 1 day
Performance assessed by complete freedom from documented AF or other atrial tachycardia (>30s), using a Holter monitor at 6-, 9-, and 12 months post ablation, after a single procedure and off AAD (following a 3 month blanking period).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 80 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
- NCT02839304
- Sponsor's protocol ID
- CS-029
- Acronym
- CryoCure2
- Status last verified
- May 2019
- First submitted
- 14 Jul 2016
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 40150915Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.
PubMed 34196991
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02839304
- Acronym / sponsor ID
- CryoCure2 / CS-029
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation Treatment | Experimental | Device: Cryoablation SystemCryoablation System: Atrial Fibrillation Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is diagnosed with paroxysmal (PAF), persistent, or long standing persistent atrial fibrillation (PsAF) for which an ablation procedure was deemed most appropriate therapy. Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year.
- Reported incidence of at least one (1) documented episode of symptomatic atrial fibrillation (AF) during the twelve months preceding trial entry (should be documented by rhythm strip or ECG).
- Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation, or intolerable side effects due to AAD.
- Left atrial size <55 mm in largest dimension as measured and image documented by preoperative imaging (CT, MRI and/or TTE)
- Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure).
Key exclusion criteria (30 listed)
- Patient had any previous left atrial ablation.
- History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
- Coronary artery bypass grafting (CABG) procedure within the last 3 months.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator.
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 SystemPulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated | Device | Catheter Ablation Treatment |
Primary outcome
The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events.
Time frame: 1 day
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events within 7 days of procedure
Time frame: 7 days
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 7 days after the procedure
Time frame: 30 days
The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 30 days after the procedure
Time frame: 12 months
Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block).
Time frame: 1 day
Technical performance assessed by AF termination targeting driver regions, when applicable
Time frame: 1 day
Technical performance assessed by complete linear block of linear lesions if deployed
Time frame: 1 day
5 secondary outcomes
Performance assessed by percentage of RF focal ablation (touch up) to reach the primary performance endpoint.
Time frame: 1 day
Performance assessed by procedural fluoroscopy times
Time frame: 1 day
Performance assessed by ablation times
Time frame: 1 day
Performance assessed by total procedure times)
Time frame: 1 day
Performance assessed by complete freedom from documented AF or other atrial tachycardia (>30s), using a Holter monitor at 6-, 9-, and 12 months post ablation, after a single procedure and off AAD (following a 3 month blanking period).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- 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.
- Derived from this study: PubMed 34196991Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation System in people with Atrial Fibrillation and Atrial Flutter, run by Adagio Medical at 3 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 9 inclusion and 30 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events. (time frame: 1 day). The study lists 7 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 NCT02839304, which also lists 2 linked publications.
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 20 Sep 2021.