Recruiting

Mitralign PTVAS

Sponsor:

Mitralign, Inc.

Code:

NCT02574650

Conditions

Chronic Symptomatic Functional Tricuspid Regurgitation

Tricuspid Valve Insufficiency

Heart Valve Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Study Details

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.

Conditions

Chronic Symptomatic Functional Tricuspid Regurgitation

Tricuspid Valve Insufficiency

Heart Valve Disease

Study ID

NCT02574650

Start date

Nov, 2015

Status verified date

Oct, 2017

Completion date

May, 2019

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

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

Primary outcome measure

  • Technical success at 30-days [ Time Frame: 30-days ]

Central Contacts and Locations

Central contacts

Gisella Blanchette

978-863-2435gblanchette@mitralign.com

Sara Vidmar

651-338-2475svidmar@mitralign.com

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Saibal Kar, MD

310-423-3977saibal.kar2@cshs.org

Principal Investigator:

Saibal Kar, MD

Kaiser Permanente

Recruiting

San Francisco, California, United States, 94115

Contacts

Cristina Casias, RN, CCRC

415-833-3480Cristina.Casias@kp.org

Principal Investigator:

Andrew Rassi, MD

MedStar Washington Hospital Center

Recruiting

Washington, D.C., District of Columbia, United States, 20010

Contacts

Lowell Satler, MD

202-877-5975satlerlowell@gmail.com

Principal Investigator:

Lowell Satler, MD

Delray Medical Center

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Laura Hudson

561-495-3145Laura.Hudson@tenethealth.com

Principal Investigator:

Brijeshwar Maini, MD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Christopher Meduri, MD

404-605-6517christopher.meduri@piedmont.org

Principal Investigator:

Christopher Meduri, MD

Northwestern University / Bluhm Cardiovascular Institute

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Stuart Rich, MD

312-695-9979srich@nm.org

Principal Investigator:

Stuart Rich, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Karen Meyer

Karen.Meyer2@allina.com

Principal Investigator:

Mario Goessl, MD, PhD

Columbia University Medical Center / New York-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Rebecca Hahn, MD

212-305-7060rth2@cumc.columbia.edu

Principal Investigator:

Rebecca Hahn, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Lisa Green

LMGreen@houstonmethodist.org

Principal Investigator:

Colin Baker, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Scott Lim, MD

434-982-1058sl9pc@virginia.edu

Principal Investigator:

Scott Lim, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Andrea Drouhard

Andrea.Drouhard@swedish.org

Principal Investigator:

Sameer Gafoor, MD

More Information

Sponsor

Mitralign, Inc.

Last update posted

Oct 27, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mitralign, Inc. on 2017-10-27.