Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• IC 1 Male or female ≥ 18 years

• IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.

• IC 3 Any of the following:

‣ Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \< 50%.

⁃ non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \< 50%

⁃ Arrhythmogenic right ventricular cardiomyopathy (ARVC)

• IC 4 Has received a market-released ICD prior to enrollment

• IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months

• IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)

• IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study

• IC 8 Willingness and ability to give an informed consent

Locations
United States
Arizona
Banner University Medical Center Phoenix
RECRUITING
Phoenix
California
University of California San Francisco
RECRUITING
San Francisco
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Weill Cornell Medical Center
RECRUITING
New York
Northwell Health- Staten Island University Hospital
RECRUITING
Staten Island
Ohio
Ohio State University
RECRUITING
Columbus
Pennsylvania
Hospital of University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Medical Center of South Carolina (MUSC)
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Texas Cardiac Arrhythmia Research Institute (TCARF)
RECRUITING
Austin
Other Locations
Canada
McGill University
RECRUITING
Montreal
Montreal Heart Institute
RECRUITING
Montreal
Contact Information
Primary
Nabil Jubran
njubran@adagiomedical.com
949 348 1188
Backup
Doug Kurschinski
dkurschinski@adagiomedical.com
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 206
Treatments
Experimental: VT Cryoablation
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT
Related Therapeutic Areas
Sponsors
Leads: Adagio Medical

This content was sourced from clinicaltrials.gov

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