Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
NCT ID: NCT02574650
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-11-30
2019-05-31
Brief Summary
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The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label
Non-randomized, open label clinical study that intends to treat up to 30 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Interventions
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Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Eligibility Criteria
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Inclusion Criteria
* ≥18 and ≤85 years old;
* NYHA II - IV;
* Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
* LVEF ≥35%
* Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29 mm/m2 (Superscript))
Exclusion Criteria
* Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
* Previous tricuspid valve repair or replacement;
* Severe coronary artery disease;
* MI or known unstable angina within the 30-days prior to the index procedure;
* Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
* Chronic oral steroid use (≥6 months);
* Life expectancy of less than 12-months
18 Years
85 Years
ALL
No
Sponsors
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Mitralign, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Hahn, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia Unviersity Medical Center / New York-Presbyterian Hospital
Christopher Meduri, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Piedmont Healthcare
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente
San Francisco, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Delray Medical Center
Delray Beach, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, United States
Houston Methodist
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Saibal Kar, MD
Role: primary
Cristina Casias, RN, CCRC
Role: primary
Lowell Satler, MD
Role: primary
Laura Hudson
Role: primary
Christopher Meduri, MD
Role: primary
Stuart Rich, MD
Role: primary
Karen Meyer
Role: primary
Rebecca Hahn, MD
Role: primary
Lisa Green
Role: primary
Scott Lim, MD
Role: primary
Andrea Drouhard
Role: primary
References
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Hahn RT, Meduri CU, Davidson CJ, Lim S, Nazif TM, Ricciardi MJ, Rajagopal V, Ailawadi G, Vannan MA, Thomas JD, Fowler D, Rich S, Martin R, Ong G, Groothuis A, Kodali S. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.
Other Identifiers
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CLPR-010
Identifier Type: -
Identifier Source: org_study_id