Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Edward Gerstenfeld
Headshot of Edward Gerstenfeld
Edward Gerstenfeld

Description

Summary

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Official Title

Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

Details

A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients.

Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation.

Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.

This IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.

Keywords

Sustained VT, cryoablation, monomorphic VT, sustained monomorphic VT, Tachycardia, Ventricular Tachycardia, cryoablation procedure, VT Cryoablation

Eligibility

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Banner University Medical Center Phoenix accepting new patients
    Phoenix Arizona 85006 United States

Lead Scientist at UCSF

  • Edward Gerstenfeld
    Dr Gerstenfeld is the Melvin Scheinman Endowed Professor of Medicine and Chief of the Section of Cardiac Electrophysiology at UCSF.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adagio Medical
ID
NCT05675865
Study Type
Interventional
Participants
Expecting 206 study participants
Last Updated