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Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. (SCOUT)

Primary Purpose

Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

About this trial

This is an interventional treatment trial for Chronic Symptomatic Functional Tricuspid Regurgitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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))

Exclusion Criteria:

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

Sites / Locations

Cedars-Sinai Medical CenterRecruiting
Kaiser PermanenteRecruiting
MedStar Washington Hospital CenterRecruiting
Delray Medical CenterRecruiting
Piedmont HealthcareRecruiting
Northwestern University / Bluhm Cardiovascular InstituteRecruiting
Minneapolis Heart Institute FoundationRecruiting
Columbia University Medical Center / New York-Presbyterian HospitalRecruiting
Houston MethodistRecruiting
University of VirginiaRecruiting
Swedish Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary safety and performance endpoints mid-term and long-term

The secondary objectives of the study are to evaluate the acute, mid-term and long-term safety of the device and effects of the device on performance, functional and quality of life parameters, as well as technical, procedural and individual patient successes.

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

Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated.

Full Information

NCT ID

NCT02574650

First Posted

October 9, 2015

Last Updated

October 26, 2017

Sponsor

Mitralign, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02574650

Brief Title

Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.

Acronym

SCOUT

Official Title

Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitralign, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-years post implantation.

6. Conditions and Keywords

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

Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open Label

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Intervention Description

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.

Primary Outcome Measure Information:

Title

Technical success at 30-days

Description

Time Frame

30-days

Secondary Outcome Measure Information:

Title

Secondary safety and performance endpoints mid-term and long-term

Description

Time Frame

24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months

Title

Description

Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated.

Time Frame

24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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)) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gisella Blanchette

Phone

978-863-2435

gblanchette@mitralign.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Vidmar

Phone

651-338-2475

svidmar@mitralign.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Hahn, MD

Organizational Affiliation

Columbia Unviersity Medical Center / New York-Presbyterian Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christopher Meduri, MD, MPH

Organizational Affiliation

Piedmont Healthcare

Official's Role

Principal Investigator

Facility Information:

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

Saibal Kar, MD

Phone

310-423-3977

saibal.kar2@cshs.org

First Name & Middle Initial & Last Name & Degree

Saibal Kar, MD

Facility Name

Kaiser Permanente

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

Cristina Casias, RN, CCRC

Phone

415-833-3480

Cristina.Casias@kp.org

First Name & Middle Initial & Last Name & Degree

Andrew Rassi, MD

Facility Name

MedStar Washington Hospital Center

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lowell Satler, MD

Phone

202-877-5975

satlerlowell@gmail.com

First Name & Middle Initial & Last Name & Degree

Lowell Satler, MD

Facility Name

Delray Medical Center

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Hudson

Phone

561-495-3145

Laura.Hudson@tenethealth.com

First Name & Middle Initial & Last Name & Degree

Brijeshwar Maini, MD

Facility Name

Piedmont Healthcare

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Meduri, MD

Phone

404-605-6517

christopher.meduri@piedmont.org

First Name & Middle Initial & Last Name & Degree

Christopher Meduri, MD

Facility Name

Northwestern University / Bluhm Cardiovascular Institute

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stuart Rich, MD

Phone

312-695-9979

srich@nm.org

First Name & Middle Initial & Last Name & Degree

Stuart Rich, MD

Facility Name

Minneapolis Heart Institute Foundation

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

Karen Meyer

Karen.Meyer2@allina.com

First Name & Middle Initial & Last Name & Degree

Mario Goessl, MD, PhD

Facility Name

Columbia University Medical Center / New York-Presbyterian Hospital

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

Rebecca Hahn, MD

Phone

212-305-7060

rth2@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Rebecca Hahn, MD

Facility Name

Houston Methodist

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

Lisa Green

LMGreen@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Colin Baker, MD

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scott Lim, MD

Phone

434-982-1058

sl9pc@virginia.edu

First Name & Middle Initial & Last Name & Degree

Scott Lim, MD

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Drouhard

Andrea.Drouhard@swedish.org

First Name & Middle Initial & Last Name & Degree

Sameer Gafoor, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28385308

Citation

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.

Results Reference

derived

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Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.

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