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TTVR Early Feasibility Study

Primary Purpose

Tricuspid Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intrepid™ TTVR System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
  • Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
  • Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
  • New York Heart Association (NYHA) Function Class II or greater
  • Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion Criteria:

  • Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
  • Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
  • Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
  • Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
  • Echocardiographic evidence of severe right ventricular dysfunction
  • Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure
  • Need for emergent or urgent surgery
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Carcinoid tricuspid regurgitation

Sites / Locations

  • University of Alabama at Birmingham (UAB) HospitalRecruiting
  • Abrazo Arizona Heart HospitalRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • California Pacific Medical CenterRecruiting
  • Emory University Hospital MidtownRecruiting
  • University of MichiganRecruiting
  • Abbott Northwestern HospitalRecruiting
  • Montefiore Medical CenterRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • OhioHealth Riverside Methodist HospitalRecruiting
  • Oregon Health & Science UniversityRecruiting
  • UPMC Pinnacle Harrisburg CampusRecruiting
  • Houston Methodist HospitalRecruiting
  • Aurora St. Lukes Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Cohort

Arm Description

Device: Intrepid TTVR System

Outcomes

Primary Outcome Measures

Rate of implant or delivery related serious adverse events
Rate of implant or delivery related serious adverse events

Secondary Outcome Measures

Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
Change in TR Grade from baseline
Change in TR Grade from baseline
Rate of no significant TV stenosis
Rate of no significant TV stenosis
Change in NYHA Class from baseline
Change in NYHA Class from baseline

Full Information

First Posted
June 4, 2020
Last Updated
October 13, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT04433065
Brief Title
TTVR Early Feasibility Study
Official Title
The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
April 30, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Multi-center, prospective, non-randomized, investigational, and pre-market.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Cohort
Arm Type
Experimental
Arm Description
Device: Intrepid TTVR System
Intervention Type
Device
Intervention Name(s)
Intrepid™ TTVR System
Intervention Description
Device: Intrepid™ TTVR System
Primary Outcome Measure Information:
Title
Rate of implant or delivery related serious adverse events
Description
Rate of implant or delivery related serious adverse events
Time Frame
Through 30 days post-procedure
Secondary Outcome Measure Information:
Title
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
Description
For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
Time Frame
During Procedure
Title
Change in TR Grade from baseline
Description
Change in TR Grade from baseline
Time Frame
Through 30 days post-procedure
Title
Rate of no significant TV stenosis
Description
Rate of no significant TV stenosis
Time Frame
Through 30 days post-procedure
Title
Change in NYHA Class from baseline
Description
Change in NYHA Class from baseline
Time Frame
Through 30 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) New York Heart Association (NYHA) Function Class II or greater Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Exclusion Criteria: Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions) Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system Echocardiographic evidence of severe right ventricular dysfunction Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure Need for emergent or urgent surgery Untreated clinically significant coronary artery disease requiring revascularization Carcinoid tricuspid regurgitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Brown
Phone
7075917775
Email
rs.tmvrtransfemoralefs@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lynnett Stahl
Email
rs.tmvrtransfemoralefs@medtronic.com
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, MD
Facility Name
Abrazo Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Byrne, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Alsabaawi
Email
khaled.alsabaawi@cshs.org
First Name & Middle Initial & Last Name & Degree
Raj Makkar
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Spies, MD
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Greenbaum, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Oakley
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Zahr, MD
Facility Name
UPMC Pinnacle Harrisburg Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemal Gada, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Goel, MD
Facility Name
Aurora St. Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Kresa
First Name & Middle Initial & Last Name & Degree
Tanvir Bajwa, MD
First Name & Middle Initial & Last Name & Degree
Eric Weiss, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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