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Cryoablation
Cryoablation for Ventricular Tachycardia (CryoCure-VT Trial)
N/A
Waitlist Available
Led By Tom DE POTTER, MD
Research Sponsored by Adagio Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months post cryoablation procedure
Awards & highlights
CryoCure-VT Trial Summary
This trial is studying a new way to treat ventricular tachycardia using a freezing method. They want to see if it is safe and works well.
Who is the study for?
This trial is for adults over 18 with a rapid, regular heartbeat known as monomorphic ventricular tachycardia. They must have an ICD (implantable cardioverter-defibrillator), be unresponsive to at least one antiarrhythmic drug, and have a left ventricular ejection fraction over 20%. Participants need to commit to the study's full length and cannot be pregnant or enrolled in another conflicting study.Check my eligibility
What is being tested?
The CryoCure-VT trial is testing the safety and effectiveness of using the Adagio Medical VT Cryoablation System for freezing areas in the heart that cause abnormal rhythms. It's a single-group study where all participants receive this new treatment.See study design
What are the potential side effects?
Potential side effects may include tissue damage at the site of ablation, arrhythmias, bleeding or clotting issues related to catheter insertion, reactions from cold temperatures used during cryoablation like frostbite internally, nerve injury causing pain or numbness.
CryoCure-VT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a procedure to treat my irregular heartbeats due to ventricular tachycardia.
Select...
My heart rhythm medication was ineffective or caused side effects.
Select...
I am willing and able to agree to participate in the study.
Select...
I am 18 years old or older.
CryoCure-VT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months post cryoablation procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months post cryoablation procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint for Clinical Performance
Primary Endpoint for Procedure Performance
Primary Endpoint for Safety
Secondary outcome measures
Descriptive Statistical Outcome - AADs use
Descriptive Statistical Outcome - Hospitalization
Descriptive Statistical Outcome - ICD shocks
+11 moreCryoCure-VT Trial Design
1Treatment groups
Experimental Treatment
Group I: Ablation in the ventricle with the Adagio VT cryoablation systemExperimental Treatment1 Intervention
all study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System
Find a Location
Who is running the clinical trial?
Adagio MedicalLead Sponsor
6 Previous Clinical Trials
545 Total Patients Enrolled
Tom DE POTTER, MDPrincipal InvestigatorOLV Ziekenhuis; Aalst-Belgium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that prevent heart rhythm correction procedures.My heart's pumping ability is above 20% as confirmed by a recent test.I am eligible for a procedure to treat my irregular heartbeats due to ventricular tachycardia.My heart rhythm medication was ineffective or caused side effects.I am willing and able to agree to participate in the study.I have not had a VT ablation in the last 4 weeks.I have a history of blood clotting or bleeding disorders.I have a history of cryoglobulinemia.I have serious heart conditions or recent heart procedures.My heart rhythm issue is due to an imbalance in body salts or thyroid problems.The doctor thinks that you are not a good fit for this study because of other health conditions or personal situations. This includes mental illness, addiction, needing a heart transplant, having a ventricular assist device, or having a terminal illness with less than 12 months to live.I am 18 years old or older.You have received or will be receiving an ICD before leaving the hospital after the procedure.My heart rhythm problem is not due to polymorphic VT.I am willing and able to follow the study's requirements.I have had more than one VT ablation or surgery for VT over 4 weeks ago.I have not had a stroke, mini-stroke, or blood clot (except DVT after surgery) in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Ablation in the ventricle with the Adagio VT cryoablation system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left for individuals to join the investigation?
"Affirmative. The clinical trial advertised on clinicaltrials.gov is still open to participants; the original posting was made in late May 2021 and updated most recently in early June 2022. 40 patients must be enrolled at 2 medical locations for this research effort to progress."
Answered by AI
What is the desired outcome of this medical experiment?
"The purpose of this clinical study, which will be assessed over the duration and 30 days post cryoablation procedure period, is to measure its Primary Performance Endpoint. Secondary outcomes comprise Descriptive Statistical Outcome - ablation time (Total ablation time), Descriptive Statistical Outcome - inducible VTs (Number of clinically induced Ventricular Tachycardias before and after cryoablation) as well as Performance - freedom from VT at 12-M off AADs (proportion of participants with no Ventricular Tachycardia lasting longer than 30 seconds at 12 months without anti-arrhythmic"
Answered by AI
What is the ultimate capacity of individuals enrolled in this trial?
"Affirmative, the data available on clinicaltrials.gov reveals that this trial is actively recruiting patients as of June 7th 2022. It was initially posted to the site on May 26th 2021 and requires 40 people at two sites for completion."
Answered by AI
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