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Cryoablation
Cryoablation for Ventricular Tachycardia (FULCRUM-VT Trial)
N/A
Recruiting
Research Sponsored by Adagio Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Refractory to, or intolerant of, at least one Class III AAD
Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12-months post cryoablation procedure
Awards & highlights
FULCRUM-VT Trial Summary
This trial will study the safety and effectiveness of a new device to treat a type of abnormal heart rhythm.
Who is the study for?
This trial is for adults (18+) with recurrent, symptomatic ventricular tachycardia linked to heart disease who've had an ICD implanted and are unresponsive or intolerant to certain medications. Participants must have a left ventricular ejection fraction of at least 20% and have experienced VT in the past 6 months. Exclusions include allergies to contrast dye, recent heart procedures, pregnancy, other conflicting medical conditions or treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the Adagio VT Cryoablation System for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). It involves using cold temperatures to destroy abnormal heart tissue causing rapid heartbeat.See study design
What are the potential side effects?
Potential side effects may include discomfort at the ablation site, bleeding, blood vessel damage, arrhythmias during procedure recovery, reactions to contrast dye used during imaging if not managed properly.
FULCRUM-VT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a bad reaction or no response to a specific heart medication.
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My heart's pumping ability is at least 20%.
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I have had at least one spontaneous blood clot in my veins in the last 6 months.
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I need a procedure to correct heart rhythm problems due to heart disease.
FULCRUM-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 Efficacy Endpoint for Pivotal Phase
Primary Procedural Endpoint for EFS and Pivotal - 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.
Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.
Secondary outcome measures
Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months
Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months
Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.
+4 moreFULCRUM-VT Trial Design
1Treatment groups
Experimental Treatment
Group I: VT CryoablationExperimental Treatment1 Intervention
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT
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Who is running the clinical trial?
Adagio MedicalLead Sponsor
7 Previous Clinical Trials
719 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have received an implantable cardioverter defibrillator (ICD) before joining the study.I have had a bad reaction or no response to a specific heart medication.The doctor thinks you may not be a good fit for the study because of other health conditions, mental illness, addiction, or if you have a very serious illness or are expected to live less than a year.My heart's pumping ability is at least 20%.I have had at least one spontaneous blood clot in my veins in the last 6 months.I haven't had a stroke, mini-stroke, or blood clot (except DVT after surgery) in the last 6 months.I have a fast heart rate due to an imbalance in body salts or thyroid issues.I have ventricular tachycardia with no known cause.I have not had a VT ablation in the last 4 weeks.I am allergic to contrast dye and it can't be managed medically.I am willing and able to follow the study's requirements.I am willing and able to give my consent for treatment.You have a blood clot in your heart within 48 hours before the procedure, as shown by a test called TTE or TEE.I have had more than one VT ablation or surgery for VT in the last 2 years.I have cardiogenic shock not caused by ongoing single-form fast heartbeats.I do not have any current infections or serious illnesses.I cannot take heparin due to health reasons.I need a procedure to correct heart rhythm problems due to heart disease.I have a history of blood clotting or bleeding disorders.I have a history of cryoglobulinemia.I have a blood vessel condition that prevents access to my left ventricle.I have serious heart conditions or recent heart procedures.
Research Study Groups:
This trial has the following groups:- Group 1: VT Cryoablation
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.
How many healthcare institutions are currently administering this experiment?
"This medical trial is being conducted at the University of California San Francisco, Icahn School of Medicine at Mount Sinai, Vanderbilt University Medical Center and other research centres. Specifically located in San Francisco, New york and Nashville respectively."
Answered by AI
Are there any remaining vacancies in this trial available for participants?
"According to the information listed on clinicaltrials.gov, this research is no longer enrolling participants as it was last amended in early January of 2023. Nonetheless, 123 other medical studies are currently searching for individuals that would like to take part in a trial."
Answered by AI
What aims has this research project set out to accomplish?
"This study is primarily assessing the rate of freedom from definite or probable device/procedure related Major Adverse Events (MAEs) within a 7-day period post-cryoablation. Secondary objectives evaluate 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 procedure's end, as well as Freedom from Ventricular Tachycardia lasting longer than 30 seconds without AADs."
Answered by AI
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