TTVR Early Feasibility Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Medtronic Cardiovascular
Study ID
NCT04433065
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

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

Interventions

  • Intrepid™ TTVR System — DEVICE
    Device: Intrepid™ TTVR System

Study Details

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Key Dates

Start date
Oct 20, 2020
Status verified
Mar 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2031

Study Design

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

Arms

  • Experimental: Primary Cohort
    Device: Intrepid TTVR System

Primary Outcome Measure

Rate of implant or delivery related serious adverse events [ Time Frame: Through 30 days post-procedure ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) HospitalBirminghamAlabama35233
Kathy Phillips
[email protected]
205-975-1888
Mustafa Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Clifton Lewis, MD (PRINCIPAL_INVESTIGATOR)
Abrazo Arizona Heart HospitalPhoenixArizona85016
Jessica Byrne
[email protected]
602-952-0002
Timothy Byrne, MD (PRINCIPAL_INVESTIGATOR)
Merick Kirshner, MD (PRINCIPAL_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Niharika Ikkurthy
[email protected]
310-423-0081
Raj Makkar, MD (PRINCIPAL_INVESTIGATOR)
Wen Cheng, MD (PRINCIPAL_INVESTIGATOR)
California Pacific Medical CenterSan FranciscoCalifornia94115
Milena Ferreira
[email protected]
415-600-5707
Christian Spies, MD (PRINCIPAL_INVESTIGATOR)
Brett Sheridan, MD (PRINCIPAL_INVESTIGATOR)
Hartford HospitalHartfordConnecticut06102
Jill Cloutier
[email protected]
860-972-2579
Robert Hagberg, MD (PRINCIPAL_INVESTIGATOR)
Talhat Azemi, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Elizabeth Charles
[email protected]
404-686-1249
Adam Greenbaum, MD (PRINCIPAL_INVESTIGATOR)
Gaetano Paone, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health System - University HospitalAnn ArborMichigan48109
Keoni Fordham
[email protected]
734-763-6551
Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR)
Steven Bolling, MD (PRINCIPAL_INVESTIGATOR)
Corewell HealthGrand RapidsMichigan49503
Elizabeth Helm
[email protected]
616-486-2080
Stephane Leung, MD (PRINCIPAL_INVESTIGATOR)
William Merhi, MD (PRINCIPAL_INVESTIGATOR)
Abbott Northwestern HospitalMinneapolisMinnesota55407
Jennifer Nguyen
[email protected]
612-863-9291
Vinayak Bapat, MD (PRINCIPAL_INVESTIGATOR)
Konstantinos Voudris, MD (PRINCIPAL_INVESTIGATOR)
Providence Saint Patrick HospitalMissoulaMontana59802
Christina Michael
[email protected]
406-329-2792
Daniel Spoon, MD (PRINCIPAL_INVESTIGATOR)
Travis Abicht, MD (PRINCIPAL_INVESTIGATOR)
New York-Presbyterian Hospital Columbia University Medical CenterNew YorkNew York10032
Lisbeth Martinez
[email protected]
973-907-6051
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
Isaac George, MD (PRINCIPAL_INVESTIGATOR)
The Mount Sinai HospitalNew YorkNew York10029
Favio Herbas
[email protected]
212-241-9914
David Adams, MD (PRINCIPAL_INVESTIGATOR)
Samin Sharma, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Angela Yang
[email protected]
718-920-6431
Azeem Latib, MD (PRINCIPAL_INVESTIGATOR)
Tadahisa Sugiura, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45242
Belinda Susie Frakes
[email protected]
513-585-1933
Puvi Seshiah, MD (PRINCIPAL_INVESTIGATOR)
Geoffrey Answini, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Lacey Maclay
[email protected]
216-844-3545
Anene C Ukaigwe, MD (PRINCIPAL_INVESTIGATOR)
Yasir Abu-Omar, MD (PRINCIPAL_INVESTIGATOR)
OhioHealth Riverside Methodist HospitalColumbusOhio43214
Martha Slyman
[email protected]
614-566-1274
Steven Yakubov, MD (PRINCIPAL_INVESTIGATOR)
Steven Duff, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University HospitalPortlandOregon97239
Ashtyn Chamberland
[email protected]
503-494-6494
Firas Zahr, MD (PRINCIPAL_INVESTIGATOR)
Howard Song, MD (PRINCIPAL_INVESTIGATOR)
UPMC Pinnacle Harrisburg CampusHarrisburgPennsylvania17101
Brittany Mashuda
[email protected]
240-575-8789
Arun Kanmanthareddy, MD (PRINCIPAL_INVESTIGATOR)
Mubashir Mumtaz, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Tia McGaughy
[email protected]
346-238-4576
Sachin Goel, MD (PRINCIPAL_INVESTIGATOR)
Michael Reardon, MD (PRINCIPAL_INVESTIGATOR)
Aurora Saint Lukes Medical CenterMilwaukeeWisconsin53125
Dena Burke
[email protected]
414-649-3490
Tanvir Bajwa, MD (PRINCIPAL_INVESTIGATOR)
William Fischer, MD (PRINCIPAL_INVESTIGATOR)

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