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Sustained VTFULCRUM-VTNCT05675865

Cryoablation for Monomorphic Ventricular Tachycardia

A study testing cryoablation procedure in people with Sustained VT, run by Adagio Medical at 15 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System 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
Sustained VT
What is being tested?
cryoablation procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
15 sitesin 2 countries
Study dates
11 Sep 2023to 30 Mar 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)
Show all 11Show fewer
  • 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

15 sites in 2 countries.

15 sites in 2 countries

United States13 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Cardiac Arrhythmia Research Institute (TCARF)

    Austin, Texas, 78705

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Medical Center of South Carolina (MUSC)

    Charleston, South Carolina, 29403

  • Ohio State University

    Columbus, Ohio, 43210

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Hospital of University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • University of California San Francisco

    San Francisco, California, 94143

  • Northwell Health- Staten Island University Hospital

    Staten Island, New York, 10305

Other trials in United States

Canada2 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • McGill University

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System 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.

This IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.

Conditions
Sustained VT
Being tested
cryoablation procedure
Keywords
cryoablation, monomorphic VT, sustained monomorphic VT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cryoablation procedureDevice

    ablation procedure for VT using the investigational device

Study groups in NCT05675865
Study groupRoleWhat they receive
VT CryoablationExperimentalall enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT
Receives: Device: cryoablation procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation 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

  2. Primary Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.

    Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.

    Measured: During Procedure

  3. Primary Efficacy Endpoint for Pivotal Phase

    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

Secondary outcomes (7)

  1. Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.

    Events will be adjudicated by an independent Clinical Events Committee (CEC).

    Measured: 1 month post cryoablation procedure

  2. Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s

    Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure.

    Measured: 6-month post cryoablation procedure

  3. Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds

    Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months (EFS) or 12 months (pivotal).

    Measured: 6-month post cryoablation procedure

  4. Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD

    Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs. Drug changes related specifically to management of atrial arrhythmias will not be included in the analysis of this endpoint (EFS

    Measured: 6-month post cryoablation procedure

  5. Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months

    All-cause mortality at 12 months

    Measured: 12-months post cryoablation procedure

  6. Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months

    Cardiac mortality at 12 months

    Measured: 12-months post cryoablation procedure

  7. Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.

    Reduction in the number of ICD shocks and number of VT related hospitalizations

    Measured: 6 and 12-months post cryoablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start11 Sep 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

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
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675865
Sponsor's protocol ID
CS-300
Acronym
FULCRUM-VT
Status last verified
Aug 2026
First submitted
14 Dec 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Weiss JP, Reddy VY, Tandri H, Richardson TD, Gerstenfeld EP, Stevenson WG, Jubran N, Grigorov I, Tung R. Ultra-Low Cryoablation for Scar-Related VT Ablation: Results From the US Early Feasibility Study. Circ Arrhythm Electrophysiol. 2026 Feb;19(2):e014095. doi: 10.1161/CIRCEP.125.014095. Epub 2026 Feb 2.

    PubMed 41623095

Questions about this trial

What is this clinical trial studying?

A study testing cryoablation procedure in people with Sustained VT, run by Adagio Medical at 15 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: under way, not looking for participants, as of the sponsor's last update on 7 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 15 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?

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 Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation 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?

On the ClinicalTrials.gov record for NCT05675865, 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 7 Aug 2026.

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