Cryoablation for Monomorphic Ventricular Tachycardia

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Adagio Medical
Study ID
NCT05675865
Status
Recruiting
Apply to this trial

Conditions

  • Sustained VT

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cryoablation procedure — DEVICE
    ablation procedure for VT using the investigational device

Study Details

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)

Key Dates

Start date
Sep 11, 2023
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
206 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VT Cryoablation
    all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT

Primary Outcome Measure

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. [ Time Frame: 7 days following the ablation procedure ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Banner University Medical Center PhoenixPhoenixArizona85006
Roderick Tung, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Edward Gerstenfeld, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Konstanitinos Aronis, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Usha Tedrow, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Jackson Liang, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Vivek Reddy, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CenterNew YorkNew York10065
Jim Cheung, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health- Staten Island University HospitalStaten IslandNew York10305
Marcin Kowalski, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Salvatore Savona, MD (PRINCIPAL_INVESTIGATOR)
Hospital of University of PennsylvaniaPhiladelphiaPennsylvania19104
Greg Supple, MD (PRINCIPAL_INVESTIGATOR)
Medical Center of South Carolina (MUSC)CharlestonSouth Carolina29403
Jeffrey Winterfield, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
William Stevenson, MD (PRINCIPAL_INVESTIGATOR)
Texas Cardiac Arrhythmia Research Institute (TCARF)AustinTexas78705
Andrea Natale, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Banner University Medical Center Phoenix· Phoenix, AZUniversity of California San Francisco· San Francisco, CAJohns Hopkins University· Baltimore, MDBrigham and Women's Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIIcahn School of Medicine at Mount Sinai· New York, NY

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