Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
SCOUT
1 other identifier
interventional
30
1 country
11
Brief Summary
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedOctober 27, 2017
October 1, 2017
2.5 years
October 9, 2015
October 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Technical success at 30-days
Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
30-days
Secondary Outcomes (2)
Secondary safety and performance endpoints mid-term and long-term
24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked
24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Study Arms (1)
Open Label
EXPERIMENTALNon-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.
Interventions
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Eligibility Criteria
You may qualify if:
- Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
- ≥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))
You may not qualify if:
- Pregnant or lactating female;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mitralign, Inc.lead
Study Sites (11)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Kaiser Permanente
San Francisco, California, 94115, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, 60611, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, 10032, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 28385308DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Hahn, MD
Columbia Unviersity Medical Center / New York-Presbyterian Hospital
- PRINCIPAL INVESTIGATOR
Christopher Meduri, MD, MPH
Piedmont Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 14, 2015
Study Start
November 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2019
Last Updated
October 27, 2017
Record last verified: 2017-10