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

Primary Purpose

Sustained VT

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryoablation procedure
Sponsored by
Adagio Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sustained VT focused on measuring cryoablation, monomorphic VT, sustained monomorphic VT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma 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)

Sites / Locations

  • Banner University Medical Center PhoenixRecruiting
  • University of California San FranciscoRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VT Cryoablation

Arm Description

all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for MVT

Outcomes

Primary Outcome Measures

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.
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.
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.
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

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.
Events will be adjudicated by an independent Clinical Events Committee (CEC).
Secondary Efficacy Endpoint - 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
Secondary Efficacy Endpoint - 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.
Secondary Efficacy Endpoint - 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
Secondary Efficacy Endpoint - VT burden
Reduction of VT burden at 6 months

Full Information

First Posted
December 14, 2022
Last Updated
October 6, 2023
Sponsor
Adagio Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05675865
Brief Title
Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)
Acronym
FULCRUM-VT
Official Title
Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adagio Medical

4. Oversight

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
Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sustained VT
Keywords
cryoablation, monomorphic VT, sustained monomorphic VT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VT Cryoablation
Arm Type
Experimental
Arm Description
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for MVT
Intervention Type
Device
Intervention Name(s)
cryoablation procedure
Intervention Description
ablation procedure for VT using the investigational device
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
7 days following the ablation procedure
Title
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.
Description
Documentation of VT non-inducibility or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.
Time Frame
During Procedure
Secondary Outcome Measure Information:
Title
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.
Description
Events will be adjudicated by an independent Clinical Events Committee (CEC).
Time Frame
1 month post cryoablation procedure
Title
Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from inducible MMVT <30s
Description
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
Time Frame
6-month post cryoablation procedure
Title
Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds
Description
Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months.
Time Frame
6-month post cryoablation procedure
Title
Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD
Description
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
Time Frame
6-month post cryoablation procedure
Title
Secondary Efficacy Endpoint - VT burden
Description
Reduction of VT burden at 6 months
Time Frame
6-month post cryoablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil Jubran
Phone
949 348 1188
Ext
207
Email
njubran@adagiomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doug Kurschinski
Email
dkurschinski@adagiomedical.com
Facility Information:
Facility Name
Banner University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roderick Tung, MD
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Gerstenfeld, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Stevenson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)

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