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Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT) (CryoCure-VT)

Primary Purpose

Monomorphic Ventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation in the ventricles with the Adagio Medical VT Cryoablation System
Sponsored by
Adagio Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monomorphic Ventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

IC 1 Male or female the ages of ≥ 18 years

IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat.

IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.

IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects).

IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation

IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study

IC 7 Willingness and ability to give an informed consent

Exclusion Criteria:

EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis

EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not.

EC 3 Any VT ablation within 4 weeks prior to enrollment

EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia

EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause

EC 6 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 the procedure
  4. Interatrial baffle, closure device, patch, or PFO occlusion device
  5. IVC filter
  6. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
  7. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
  8. Cardiac myxoma
  9. Significant congenital anomaly
  10. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
  11. Mechanical aortic or mitral valve

EC 7 Any previous history of cryoglobulinemia

EC 8 History of blood clotting or bleeding disease

EC 9 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 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up

EC 11 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 12 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

  • Onze Lieve VrouwziekenhuisRecruiting
  • McGill University Health CentreRecruiting
  • Montreal Hear InstituteRecruiting
  • Nemocnice na HomolceRecruiting
  • CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-LévêqueRecruiting
  • Herzzentrum Leipzig Universitätsklinik für KardiologieRecruiting
  • St Antonius ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablation in the ventricle with the Adagio VT cryoablation system

Arm Description

all study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System

Outcomes

Primary Outcome Measures

Primary Endpoint for Safety
An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure
Primary Endpoint for Clinical Performance
an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.
Primary Endpoint for Procedure Performance
an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure

Secondary Outcome Measures

Safety - freedom from procedure or device related SAE
The proportion of study subjects with probable or definite device or procedure related serious adverse events (SAEs) including MAEs as described above, or serious adverse device effects (SADEs) between 30-days up to 12 months post-procedure.
Performance - non-inducible sustained monomorphic VT
The proportion of study subjects with non-inducible sustained monomorphic VT at the end of the ablation procedure
Performance - freedom from VT at 12-M off AADs
The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months without the use of anti-arrhythmic drugs (AADs)
Performance - freedom from VT at 12-M on previously failed AADs
The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months with previously failed anti-arrhythmic drugs (AADs)
Performance - VT burden
Reduction of VT burden at 6 and 12 months
Descriptive Statistical Outcome - fluoroscopy time
Procedure fluoroscopy time
Descriptive Statistical Outcome - ablation time
Total ablation time
Descriptive Statistical Outcome - procedure time
Total ablation time
Descriptive Statistical Outcome - cryoablation lesions
Number and location of cryoablation lesions
Descriptive Statistical Outcome - inducible VTs
Number of inducible clinical VTs before and after cryoablation
Descriptive Statistical Outcome - ICD shocks
Number of appropriate and inappropriate ICD therapies (shocks and pacing) in the follow up period
Descriptive Statistical Outcome - ablation strategies
Mapping and ablation strategies utilized during the ablation procedure
Descriptive Statistical Outcome - Hospitalization
Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months
Descriptive Statistical Outcome - AADs use
Recording of the use of AADs in the follow up period

Full Information

First Posted
May 11, 2021
Last Updated
January 9, 2023
Sponsor
Adagio Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04893317
Brief Title
Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)
Acronym
CryoCure-VT
Official Title
Cryoablation for Monomorphic Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
Detailed Description
Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure. A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monomorphic Ventricular Tachycardia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ablation in the ventricle with the Adagio VT cryoablation system
Arm Type
Experimental
Arm Description
all study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System
Intervention Type
Device
Intervention Name(s)
Ablation in the ventricles with the Adagio Medical VT Cryoablation System
Intervention Description
The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias
Primary Outcome Measure Information:
Title
Primary Endpoint for Safety
Description
An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure
Time Frame
during and 30 days post cryoablation procedure
Title
Primary Endpoint for Clinical Performance
Description
an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period.
Time Frame
6 month post cryoablation procedure
Title
Primary Endpoint for Procedure Performance
Description
an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure
Time Frame
at the end of the cryoablation procedure
Secondary Outcome Measure Information:
Title
Safety - freedom from procedure or device related SAE
Description
The proportion of study subjects with probable or definite device or procedure related serious adverse events (SAEs) including MAEs as described above, or serious adverse device effects (SADEs) between 30-days up to 12 months post-procedure.
Time Frame
12 months post cryoablation procedure
Title
Performance - non-inducible sustained monomorphic VT
Description
The proportion of study subjects with non-inducible sustained monomorphic VT at the end of the ablation procedure
Time Frame
at the end of the cryoablation procedure
Title
Performance - freedom from VT at 12-M off AADs
Description
The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months without the use of anti-arrhythmic drugs (AADs)
Time Frame
12 months post cryoablation procedure
Title
Performance - freedom from VT at 12-M on previously failed AADs
Description
The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months with previously failed anti-arrhythmic drugs (AADs)
Time Frame
12 months post cryoablation procedure
Title
Performance - VT burden
Description
Reduction of VT burden at 6 and 12 months
Time Frame
6 and 12 months post cryoablation procedure
Title
Descriptive Statistical Outcome - fluoroscopy time
Description
Procedure fluoroscopy time
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - ablation time
Description
Total ablation time
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - procedure time
Description
Total ablation time
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - cryoablation lesions
Description
Number and location of cryoablation lesions
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - inducible VTs
Description
Number of inducible clinical VTs before and after cryoablation
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - ICD shocks
Description
Number of appropriate and inappropriate ICD therapies (shocks and pacing) in the follow up period
Time Frame
12 months post cryoablation procedure
Title
Descriptive Statistical Outcome - ablation strategies
Description
Mapping and ablation strategies utilized during the ablation procedure
Time Frame
at the end of the cryoablation procedure
Title
Descriptive Statistical Outcome - Hospitalization
Description
Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months
Time Frame
12 months post cryoablation procedure
Title
Descriptive Statistical Outcome - AADs use
Description
Recording of the use of AADs in the follow up period
Time Frame
12 months post cryoablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IC 1 Male or female the ages of ≥ 18 years IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat. IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure. IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects). IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 7 Willingness and ability to give an informed consent Exclusion Criteria: EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not. EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Structural heart disease as described below: Class IV heart failure Aortic aneurysm Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure Interatrial baffle, closure device, patch, or PFO occlusion device IVC filter Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma Significant congenital anomaly Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure Mechanical aortic or mitral valve EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 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 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up EC 11 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 12 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
Didier BILLY, PhD
Phone
+31654954128
Email
dbilly@adagiomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil JUBRAN
Phone
+1 949-348-1188
Ext
207
Email
njubran@adagiomedical.com
Facility Information:
Facility Name
Onze Lieve Vrouwziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom DE POTTER, MD
Phone
+3253724168
Email
tom.de.potter@olvz-aalst.bet.be
First Name & Middle Initial & Last Name & Degree
Hedwig BATJOENS
Phone
+3253724168
Email
hedwig.batjoens@olvz-aalst.be
First Name & Middle Initial & Last Name & Degree
Tom De Potter, MD
Facility Name
McGill University Health Centre
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
Facility Name
Montreal Hear Institute
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia Dydra, MD
First Name & Middle Initial & Last Name & Degree
Katia Dydra, MD
Facility Name
Nemocnice na Homolce
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Neužil, Prof
First Name & Middle Initial & Last Name & Degree
Petr Neužil, Professor
Facility Name
CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric SACHER, Prof
First Name & Middle Initial & Last Name & Degree
Frédéric SACHER, Professor
Facility Name
Herzzentrum Leipzig Universitätsklinik für Kardiologie
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darma Angeliki, MD
First Name & Middle Initial & Last Name & Degree
Darma Angeliki, MD
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, Prof
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

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