Monomorphic Ventricular TachycardiaCryoCure-VTNCT04893317
Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)
A study testing Ablation in the ventricles with the Adagio Medical VT Cryoablation System in people with Monomorphic Ventricular Tachycardia, run by Adagio Medical at 7 sites in 6 countries.
Trial summary
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monomorphic Ventricular Tachycardia
- What is being tested?
- Ablation in the ventricles with the Adagio Medical VT Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 26 May 2021to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IC 1 Male or female the ages of ≥ 18 years
- IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat.
- IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.
- IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects).
- IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation
- IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
- IC 7 Willingness and ability to give an informed consent
Who cannot join
- EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis
- EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not.
- EC 3 Any VT ablation within 4 weeks prior to enrollment
- EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia
- EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- EC 6 Structural heart disease as described below:
Show all 23Show fewer
- Class IV heart failure
- Aortic aneurysm
- Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
- Interatrial baffle, closure device, patch, or PFO occlusion device
- IVC filter
- Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
- Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
- Cardiac myxoma
- Significant congenital anomaly
- Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
- Mechanical aortic or mitral valve
- EC 7 Any previous history of cryoglobulinemia
- EC 8 History of blood clotting or bleeding disease
- EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.
- EC 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up
- EC 11 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 12 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, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Canada2 sites
McGill University Health Centre
Montreal
Montreal Hear Institute
Montreal
France1 site
CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
Bordeaux
About this study
Official title: Cryoablation for Monomorphic Ventricular Tachycardia
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
Read the detailed description
Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure.
A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.
- Conditions
- Monomorphic Ventricular Tachycardia
- Being tested
- Ablation in the ventricles with the Adagio Medical VT Cryoablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation in the ventricles with the Adagio Medical VT Cryoablation SystemDevice
The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| Ablation in the ventricle with the Adagio VT cryoablation system | Experimental | all study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System Receives: Device: Ablation in the ventricles with the Adagio Medical VT Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Are Free From Definite or Probable Device/Procedure Related Major Adverse Events (MAEs)
An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days 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
- Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation
- Access site complications requiring medical or surgical intervention
- Pericarditis
- Heart block requiring a permanent pacemaker
- Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent DSMB to be probably or definitely related to the Adagio System.
Measured: during or within 30 days following the cryoablation procedure
6-month Freedom From Sustained VT (>30 s) or Appropriate ICD Intervention (Shock or Anti-tachycardia Pacing)
The primary clinical performance endpoint is an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.
Measured: 6 month post cryoablation procedure
Proportion of Patients With Non-inducible Clinical VT at the Conclusion of the Ablation Procedure
The primary procedural performance endpoint is an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure.
Measured: at the end of the cryoablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start26 May 2021
- Primary completion30 Jun 2024
- Study completion30 Sep 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Monomorphic Ventricular TachycardiaStudies 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
- 64 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
- NCT04893317
- Sponsor's protocol ID
- CS-098
- Acronym
- CryoCure-VT
- Status last verified
- Jul 2026
- First submitted
- 11 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma A, Essebag V, Neuzil P, Dyrda K, Balt J, Dinov B, Darma A, Arya A, Sacher F, Reddy VY, Boersma L, Grigorov I, De Potter T. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Europace. 2024 Mar 30;26(4):euae076. doi: 10.1093/europace/euae076.
PubMed 38582974De Potter T, Balt JC, Boersma L, Sacher F, Neuzil P, Reddy V, Grigorov I, Verma A. First-in-Human Experience With Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. JACC Clin Electrophysiol. 2023 May;9(5):686-691. doi: 10.1016/j.jacep.2022.11.017. Epub 2023 Jan 18.
PubMed 36752466
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation for Monomorphic Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT04893317
- Acronym / sponsor ID
- CryoCure-VT / CS-098
- Conditions
- Monomorphic Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 13 Oct 2026
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, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
Detailed description
Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure.
A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation in the ventricle with the Adagio VT cryoablation system | Experimental | Device: Ablation in the ventricles with the Adagio Medical VT Cryoablation Systemall study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- IC 1 Male or female the ages of ≥ 18 years
- IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat.
- IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.
- IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects).
- IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation
Key exclusion criteria (23 listed)
- EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis
- EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not.
- EC 3 Any VT ablation within 4 weeks prior to enrollment
- EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia
- EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
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 |
|---|---|---|
| Ablation in the ventricles with the Adagio Medical VT Cryoablation SystemThe Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias | Device | Ablation in the ventricle with the Adagio VT cryoablation system |
Primary outcome
Proportion of Subjects Who Are Free From Definite or Probable Device/Procedure Related Major Adverse Events (MAEs)
Time frame: during or within 30 days following the cryoablation procedure
An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days 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 * Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation * Access site complications requiring medical or surgical intervention * Pericarditis * Heart block requiring a permanent pacemaker * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent DSMB to be probably or definitely related to the Adagio System.
6-month Freedom From Sustained VT (>30 s) or Appropriate ICD Intervention (Shock or Anti-tachycardia Pacing)
Time frame: 6 month post cryoablation procedure
The primary clinical performance endpoint is an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.
Proportion of Patients With Non-inducible Clinical VT at the Conclusion of the Ablation Procedure
Time frame: at the end of the cryoablation procedure
The primary procedural performance endpoint is an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38582974Verma A, Essebag V, Neuzil P, Dyrda K, Balt J, Dinov B, Darma A, Arya A, Sacher F, Reddy VY, Boersma L, Grigorov I, De Potter T. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Europace. 2024 Mar 30;26(4):euae076. doi: 10.1093/europace/euae076.
- Derived from this study: PubMed 36752466De Potter T, Balt JC, Boersma L, Sacher F, Neuzil P, Reddy V, Grigorov I, Verma A. First-in-Human Experience With Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. JACC Clin Electrophysiol. 2023 May;9(5):686-691. doi: 10.1016/j.jacep.2022.11.017. Epub 2023 Jan 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in the ventricles with the Adagio Medical VT Cryoablation System in people with Monomorphic Ventricular Tachycardia, run by Adagio Medical at 7 sites in 6 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 7 inclusion and 23 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Belgium, Czechia, France, Germany and 1 more country. 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 13 Oct 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?
Proportion of Subjects Who Are Free From Definite or Probable Device/Procedure Related Major Adverse Events (MAEs) (time frame: during or within 30 days following the cryoablation procedure). 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 NCT04893317, 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 13 Oct 2026.