Ventricular Tachycardia, SustainedFULCRUM-VTNCT07650032
Cryoablation for Monomorphic Ventricular Tachycardia (VTS)
A study testing Ultra Low Temperature Ablation (ULTA) in people with Ventricular Tachycardia, Sustained and Ventricular Tachycardia, Monomorphic, run by Adagio Medical at 10 sites in 2 countries.
Trial summary
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic
- What is being tested?
- Ultra Low Temperature Ablation (ULTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Aug 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ≥ 18 years
- IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.
- IC 3 Any of the following:
- Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF < 50%.
- non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF < 50%
- Arrhythmogenic right ventricular cardiomyopathy (ARVC)
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- IC 4 Has received a market-released ICD prior to enrollment
- IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
- IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)
- IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
- IC 8 Willingness and ability to give an informed consent
Who cannot join
- EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
- EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use
- EC 3 VTs due to any of the following causes:
- Idiopathic VT
- Automaticity or triggered activity
- Bundle Branch Reentry (BBR)
Show all 38Show fewer
- Any focal tachycardia (e.g., papillary, RVOT)
- Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- EC 4 NICM patients only, if any of the following apply:
- Congenital condition that limits access to the left or right ventricles
- Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
- Active inflammatory processes (e.g., myocarditis) within the past 120 days
- Sarcoidosis
- Hypertrophic cardiomyopathy
- Drug- or alcohol-induced cardiomyopathy
- EC 5 Any VT ablation within 4 weeks prior to enrollment
- EC 6 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
- EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT
- EC 8 Any other cardiovascular conditions as described below:
- Class IV heart failure
- Aortic aneurysm
- Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
- Interatrial baffle, closure device, patch, or PFO occlusion device
- Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
- Acute MI or unstable angina in the previous 60 days
- Mechanical mitral or aortic valve
- Cardiac myxoma
- Significant congenital heart disease
- EC 9 Acute illness or active systemic infection
- EC 10 Any previous history of cryoglobulinemia
- EC 11 History of blood clotting or bleeding disease
- EC 12 Peripheral vascular disease that precludes LV access
- EC 13 Contraindication to heparin
- EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
- EC 15 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 16 Pregnant, or anticipated pregnancy during study follow-up
- EC 17 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 18 Any other condition (e.g., ARVC with extensive free wall scarring) 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
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Doug Kurschinski contact
10 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Medical Center of South Carolina (MUSC)
Charleston, South Carolina, 29403
- Recruiting
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
Mark Lee, MD, 562-933-2000, markyounglee@gmail.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Ajay Pillai, MD, ajay.pillai@vcuhealth.org
- Recruiting
Northwell Health- Staten Island University Hospital
Staten Island, New York, 10305
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
Montreal, Quebec, H3G 1A4
Atul Verma, MD
- Recruiting
Montreal Hear Institute
Montreal
Katia Dydra, MD
About this study
Official title: Cryoablation for Monomorphic Ventricular Tachycardia IDE Study
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
Read the detailed description
A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.
The VTS study is being initiated to collect safety and effectiveness data and support future PMA supplement marketing application.
- Being tested
- Ultra Low Temperature Ablation (ULTA)
- Keywords
- cryoablation, monomorphic VT, sustained monomorphic VT, Ultra Low Temperature Ablation, ULTA
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Low Temperature Ablation (ULTA)Device
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)
| Study group | Role | What they receive |
|---|---|---|
| VT Cryoablation | Experimental | all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT Receives: Device: Ultra Low Temperature Ablation (ULTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.
Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.
Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute 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 Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Measured: 7 days following the ablation procedure
Primary Efficacy Endpoint - Freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure
Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for > 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
Measured: 6 months after the procedure
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure
Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure
Measured: at the end of the ablation procedure
Secondary outcomes (2)
Secondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure
Secondary Safety Endpoint is defined as freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC).
Measured: 12-months post ablation procedure
Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months
Secondary Efficacy Endpoint is defined as freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 12 months
Measured: 12-months post ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia, SustainedStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adagio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650032
- Sponsor's protocol ID
- CS-300 Rev.H
- Acronym
- FULCRUM-VT
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 IDE Study
- ClinicalTrials.gov ID
- NCT07650032
- Acronym / sponsor ID
- FULCRUM-VT / CS-300 Rev.H
- Keywords
- cryoablation, monomorphic VT, sustained monomorphic VT, Ultra Low Temperature Ablation, ULTA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Jun 2026 (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.
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
Detailed description
A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.
The VTS study is being initiated to collect safety and effectiveness data and support future PMA supplement marketing application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT Cryoablation | Experimental | Device: Ultra Low Temperature Ablation (ULTA)all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- IC 1 Male or female ≥ 18 years
- IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.
- IC 3 Any of the following:
- IC 4 Has received a market-released ICD prior to enrollment
- IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
Key exclusion criteria (38 listed)
- EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
- EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use
- EC 3 VTs due to any of the following causes:
- EC 4 NICM patients only, if any of the following apply:
- EC 5 Any VT ablation within 4 weeks prior to enrollment
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 |
|---|---|---|
| Ultra Low Temperature Ablation (ULTA)ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console) | Device | VT Cryoablation |
Primary outcome
Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.
Time frame: 7 days following the ablation procedure
Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute 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 Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Primary Efficacy Endpoint - Freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure
Time frame: 6 months after the procedure
Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for > 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure
Time frame: at the end of the ablation procedure
Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure
2 secondary outcomes
Secondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure
Time frame: 12-months post ablation procedure
Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months
Time frame: 12-months post ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Doug Kurschinski contact
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Low Temperature Ablation (ULTA) in people with Ventricular Tachycardia, Sustained and Ventricular Tachycardia, Monomorphic, run by Adagio Medical at 10 sites in 2 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 11 inclusion and 38 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: looking for participants now, 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 10 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil Jubran, MS (949 329 2494 ext. 207, njubran@adagiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. (time frame: 7 days following the ablation 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?
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.