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Cryoablation for Ventricular Tachycardia (FULCRUM-VT Trial)
FULCRUM-VT Trial Summary
This trial will study the safety and effectiveness of a new device to treat a type of abnormal heart rhythm.
FULCRUM-VT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFULCRUM-VT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FULCRUM-VT Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: VT Cryoablation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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