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

Sponsor
Adagio Medical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05675865
Collaborator
(none)
20
4
1
10
5
0.5

Study Details

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
  • Device: cryoablation procedure
N/A

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
Anticipated 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)
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

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. [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. [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. [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 [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 [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 [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 [6-month post cryoablation procedure]

    Reduction of VT burden at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Banner University Medical Center Phoenix Phoenix Arizona United States 85006
2 University of California San Francisco San Francisco California United States 94143
3 Icahn School of Medicine at Mount Sinai New York New York United States 10029
4 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Adagio Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adagio Medical
ClinicalTrials.gov Identifier:
NCT05675865
Other Study ID Numbers:
  • CS-300
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Adagio Medical
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023