Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AtaCor Medical, Inc.
Study ID
NCT07324031
Status
Recruiting
Apply to this trial

Conditions

  • Ventricular Arrythmia
  • Ventricular Fibrillation
  • Ventricular Tachycardia

Eligibility Criteria

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

Interventions

  • Atala™ lead and EV-ICD Pulse Generator — DEVICE
    Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.

Study Details

The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System. The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.

Key Dates

First listed
Jan 7, 2026
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Parasternal EV-ICD System
    Subjects implanted with the Atala™ lead and EV-ICD pulse generator

Primary Outcome Measure

Freedom from MADEs [ Time Frame: Through 6 months post-implant ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258
Rahul Doshi, MD
Rahul Doshi, MD (PRINCIPAL_INVESTIGATOR)
St. Bernards Heart and VascularJonesboroArkansas72401
Devi Nair, MD
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
UC San Diego HealthLa JollaCalifornia92037
Ulrika Birgersdotter-Green, MD
Ulrika Birgersdotter-Green, MD (PRINCIPAL_INVESTIGATOR)
Providence Medical FoundationOrangeCalifornia92868
Thuy Le, MD
Thuy Le, MD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterSanta MonicaCalifornia90404
Shephal Doshi, MD
Shephal Doshi, MD (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Cyrus Hadadi, MD
Cyrus Hadadi, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical Center of FloridaMiami BeachFlorida33140
Raul Weiss, MD
Raul Weiss, MD (PRINCIPAL_INVESTIGATOR)
AdventHealthOrlandoFlorida32803
Naushad Shaik, MD
Naushad Shaik, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30308
Mikhael El Chami, MD
Mikhael El Chami, MD (PRINCIPAL_INVESTIGATOR)
Endeavor HealthGlenviewIllinois60026
Mark Metzl, MD
Mark Metzl, MD (PRINCIPAL_INVESTIGATOR)
Baptist HealthLexingtonKentucky40503
Johan Aasbo, DO
Johan Aasbo, DO (PRINCIPAL_INVESTIGATOR)
John Hopkins MedicalBaltimoreMaryland21287
Edward Powers, MD
Edward Powers, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55902
Paul Friedman, MD
Paul Friedman, MD (PRINCIPAL_INVESTIGATOR)
Cooper HealthVoorhees TownshipNew Jersey08043
Andrea Russo, MD
Andrea Russo, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthManhassetNew York11030
Laurence Epstein, MD
Laurence Epstein, MD (PRINCIPAL_INVESTIGATOR)
Advocate/Atrium Health - Sanger Heart and VascularCharlotteNorth Carolina28204
Satish Misra, MD
Satish Misra, MD (PRINCIPAL_INVESTIGATOR)
East Carolina Heart Institute at ECUGreenvilleNorth Carolina27834
Rajesekhar Nekkanti, MD
Rajesekhar Nekkanti, MD (PRINCIPAL_INVESTIGATOR)
North Carolina Heart and VascularRaleighNorth Carolina27607
Sidharth Shah, MD
Sidharth Shah, MD (PRINCIPAL_INVESTIGATOR)
Advocate/Atrium Health - Wake Forest BaptistWinston-SalemNorth Carolina27157
Satish Misra, MD
Satish Misra, MD (PRINCIPAL_INVESTIGATOR)
Novant HealthWinston-SalemNorth Carolina27103
Michael Drucker, MD
Michael Drucker, MD (PRINCIPAL_INVESTIGATOR)
The Carl & Edyth Lindner Center for Research and Education at The Christ HospitalCincinnatiOhio45219
Daniel Pelchovitz, MD
Daniel Pelchovitz, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals of ClevelandClevelandOhio44106
Judith Mackall, MD
Judith Mackall, MD (PRINCIPAL_INVESTIGATOR)
OhioHealth Research InstituteColumbusOhio43228
Anish Amin, MD
Anish Amin, MD (PRINCIPAL_INVESTIGATOR)
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033
Soraya Samii, MD
Soraya Samii, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Robert Schaller, MD
Robert Schaller, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Anne Kroman, DO
Anne Kroman, DO (PRINCIPAL_INVESTIGATOR)
Texas Cardiac Arrhythmia ResearchAustinTexas78705
Amin Al-Ahmad, MD
Amin Al-Ahmad, MD (PRINCIPAL_INVESTIGATOR)

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