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The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

RECRUITINGPhase 4Sponsored by University of Rochester
Actively Recruiting
PhasePhase 4
SponsorUniversity of Rochester
Started2022-05-27
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations19 sites
View on ClinicalTrials.gov →

NCT05034432

Summary

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age \> 18 years
* Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
* Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
* History of treated or monitored sustained (i.e., \>30 seconds in duration ) VT or VF episode within the past 5 years.

Exclusion Criteria:

* Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
* Participation in other clinical trials (observational registries are allowed with approval)
* Unable or unwilling to provide informed consent

Conditions3

ArrythmiaCardiomyopathiesHeart Disease

Locations19 sites

Banner University Medical Center
Phoenix, Arizona, 85006
Matt Freeman623-293-3945mathew.freeman@bannerhealth.com
UCLA Cardiac Arrthmia Center
Los Angeles, California, 90095
Julie Sorg310-259-7327jsorg@mednet.ucla.edu
University of California San Francisco
San Francisco, California, 94143
Maria Eleni Varympopioti415-910-5046mariaeleni.varympopioti@ucsf.edu
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Jamie Guillergan202-877-5902jamie.s.guillergan@medstar.net
Piedmont Heart Institute
Atlanta, Georgia, 30309
Megan Kopp404-605-5003megan.kopp@piedmont.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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