Cryoablation for Monomorphic Ventricular Tachycardia (FULCRUM-VT)

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)

Study Overview

• Status: Recruiting
• Conditions: Sustained VT
• Intervention / Treatment: Device: cryoablation procedure

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.

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil Jubran; Phone Number: 207 949 348 1188; Email: njubran@adagiomedical.com
• Study Contact Backup: Name: Doug Kurschinski; Email: dkurschinski@adagiomedical.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Montreal Heart Institute
      • Principal Investigator: Katia Dydra, MD
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University
      • Principal Investigator: Atul Verma, MD
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Banner University Medical Center Phoenix
      • Principal Investigator: Roderick Tung, MD
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Principal Investigator: Edward Gerstenfeld, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Konstanitinos Aronis, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Principal Investigator: Usha Tedrow, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Jackson Liang, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Vivek Reddy, MD
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical Center
      • Principal Investigator: Jim Cheung, MD
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Northwell Health- Staten Island University Hospital
      • Principal Investigator: Marcin Kowalski, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: Salvatore Savona, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of University of Pennsylvania
      • Principal Investigator: Greg Supple, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Recruiting
      • Medical Center of South Carolina (MUSC)
      • Principal Investigator: Jeffrey Winterfield, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: William Stevenson, MD
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Cardiac Arrhythmia Research Institute (TCARF)
      • Principal Investigator: Andrea Natale, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (IC):

• 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):

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VT Cryoablation; all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT	Device: cryoablation procedure; ablation procedure for VT using the investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days following the ablation procedure
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.	During Procedure
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.	6 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month post cryoablation procedure
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.	6-month post cryoablation procedure
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).	6-month post cryoablation procedure
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	6-month post cryoablation procedure
Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months	All-cause mortality at 12 months	12-months post cryoablation procedure
Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months	Cardiac mortality at 12 months	12-months post cryoablation procedure
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	6 and 12-months post cryoablation procedure

Collaborators and Investigators

• Sponsor: Adagio Medical

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cryoablation; monomorphic VT; sustained monomorphic VT
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: CS-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No