Cryoablation for Monomorphic Ventricular Tachycardia (VTS) (FULCRUM-VT)

June 11, 2026 updated by: Adagio Medical

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Montreal, Canada
        • Montreal Hear Institute
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Long Beach Medical Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • New York
      • Staten Island, New York, United States, 10305
        • Northwell Health- Staten Island University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical Center of South Carolina (MUSC)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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:

    1. Idiopathic VT
    2. Automaticity or triggered activity
    3. Bundle Branch Reentry (BBR)
    4. Any focal tachycardia (e.g., papillary, RVOT)
    5. 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:

    1. Congenital condition that limits access to the left or right ventricles
    2. Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
    3. Active inflammatory processes (e.g., myocarditis) within the past 120 days
    4. Sarcoidosis
    5. Hypertrophic cardiomyopathy
    6. 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:

    1. Class IV heart failure
    2. Aortic aneurysm
    3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
    4. Interatrial baffle, closure device, patch, or PFO occlusion device
    5. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
    6. Acute MI or unstable angina in the previous 60 days
    7. Mechanical mitral or aortic valve
    8. Cardiac myxoma
    9. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VT Cryoablation
all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT
Device: Ultra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
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 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.
7 days following the ablation procedure
Primary Efficacy Endpoint
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.
6 months after the procedure
Primary Procedural Endpoint
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
at the end of the ablation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoint
Time Frame: 12-months post 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 cryoablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC).
12-months post ablation procedure
Secondary Efficacy Endpoint
Time Frame: 12-months post ablation procedure
Secondary Efficacy Endpoint is defined as freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 12 months
12-months post ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adagio Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS-300 Rev.H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventricular Tachycardia, Monomorphic

Clinical Trials on Ultra Low Temperature Ablation (ULTA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings