Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS) (FULCRUM-VT)

• ClinicalTrials.gov Identifier: NCT05675865
• Recruitment Status: Recruiting
• First Posted: January 9, 2023
• Last Update Posted: January 30, 2024
• Sponsor: Adagio Medical
• Information provided by (Responsible Party): Adagio Medical

Study Description

Brief Summary:

The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)

Condition or disease	Intervention/treatment	Phase
Sustained VT	Device: cryoablation procedure	Not Applicable

Detailed Description:

A prospective, single-arm, multi-center, open label, pre-market, early feasibility clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of SMVT.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)
• Actual Study Start Date: September 11, 2023
• Estimated Primary Completion Date: December 30, 2025
• Estimated Study Completion Date: March 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Primary Endpoint for Safety - Analysis of the proportion of subjects with freedom from definite or probable device/procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure. [ Time Frame: 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.
2. Primary Procedural Endpoint - 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. [ Time Frame: During Procedure ]
   Documentation of VT non-inducibility or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.

Secondary Outcome Measures :

1. Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device/procedure related Major Adverse Events (MAEs) that occur within 30 days following the cryoablation procedure. [ Time Frame: 1 month post cryoablation procedure ]
   Events will be adjudicated by an independent Clinical Events Committee (CEC).
2. Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from inducible MMVT <30s [ Time Frame: 6-month post cryoablation procedure ]
   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
3. Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds [ Time Frame: 6-month post cryoablation procedure ]
   Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months.
4. Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD [ Time Frame: 6-month post cryoablation procedure ]
   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
5. Secondary Efficacy Endpoint - VT burden [ Time Frame: 6-month post cryoablation procedure ]
   Reduction of VT burden at 6 months

Eligibility Criteria

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

Criteria

Inclusion Criteria (IC):

• IC 1 Male or female ≥ 18 years
• IC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular Tachycardia
• IC 3 Has received an ICD prior to enrollment
• IC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
• IC 5 Refractory to, or intolerant of, at least one Class III AAD
• IC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months
• 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 Idiopathic VT
• EC 3 Any VT ablation within 4 weeks prior to enrollment
• EC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
• EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
• EC 6 Cardiogenic shock, unless it is due to incessant monomorphic VT

• EC 7 Structural heart disease 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. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
  9. Cardiac myxoma
  10. Significant congenital heart disease
• EC 8 Acute illness or active systemic infection
• EC 9 Any previous history of cryoglobulinemia
• EC 10 History of blood clotting or bleeding disease
• EC 11 Peripheral vascular disease that precludes LV access
• EC 12 Contraindication to heparin
• EC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
• EC 14 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 15 Pregnant, or anticipated pregnancy during study follow-up
• EC 16 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 17 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)

Contacts and Locations

Contacts

Contact: Nabil Jubran; 949 348 1188 ext 207; njubran@adagiomedical.com

Contact: Doug Kurschinski; dkurschinski@adagiomedical.com

Locations

United States, Arizona

Banner University Medical Center Phoenix; Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator: Roderick Tung, MD

United States, California

University of California San Francisco; Recruiting

San Francisco, California, United States, 94143

Principal Investigator: Edward Gerstenfeld, MD

United States, New York

Icahn School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

Principal Investigator: Vivek Reddy, MD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: William Stevenson, MD

Sponsors and Collaborators

Adagio Medical

More Information

• Responsible Party: Adagio Medical
• ClinicalTrials.gov Identifier: NCT05675865
• Other Study ID Numbers: CS-300
• First Posted: January 9, 2023
• Last Update Posted: January 30, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Adagio Medical:

cryoablation; monomorphic VT; sustained monomorphic VT

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes