Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) (SCOUT-II)

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

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.

Study Overview

• Status: Unknown
• Conditions: Heart Valve Disease; Tricuspid Valve Insufficiency; Chronic Symptomatic Functional Tricuspid Regurgitation
• Intervention / Treatment: Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Detailed Description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Keating; Phone Number: 978-863-2445; Email: pkeating@mitralign.com
• Study Contact Backup: Name: Gisella Blanchette; Phone Number: 978.863.2435; Email: gblanchette@mitralign.com

Study Locations

• Germany
  • Berlin, Germany, 10967
    • Recruiting
    • Vivantes Klinikum Am Urban
    • Contact: Maria Schuppe; Phone Number: +49 030 130 22 5101; Email: maria.schuppe@vivantes.de
    • Sub-Investigator: Hueseyin Ince, MD
    • Principal Investigator: Stephan Kische, MD
  • Bernau bei Berlin, Germany, 16321
    • Recruiting
    • Herzzentrum Brandenburg in Bernau
    • Contact: Daniela Bettin; Phone Number: +49 33 3869 4604; Email: d.bettin@immanuel.de
    • Principal Investigator: Christian Butter, MD
    • Sub-Investigator: Michael Neuss, MD
  • Frankfurt, Germany, 60389
    • Recruiting
    • Cardiovascular Center Frankfurt
    • Contact: Sabine de Bruijn; Phone Number: +49 69 9794 7653; Email: s.debruijn@cvcfrankfurt.de
    • Sub-Investigator: Markus Reinartz, MD
  • Hamburg, Germany, 22527
    • Recruiting
    • Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
    • Contact: Stefanie Bohme; Phone Number: +49 40 889006 830; Email: Boehme@herz-hh.de
    • Principal Investigator: Joachim Schofer, MD
    • Sub-Investigator: Claudia Tiburtius, MD
  • Leipzig, Germany, 04289
    • Recruiting
    • Herzzentrum Leipzig - Universitätsklinik
    • Contact: Anne Kathrin Funkat; Phone Number: +49 341 865 1587; Email: Anne-kathrin.funkat@leipzig-heart.de
    • Sub-Investigator: Joerg Seeburger, MD
  • Munich, Germany, 80636
    • Recruiting
    • German Heart Center Munich
    • Contact: Annemarie Stroh, PhD; Phone Number: +49 (0) 89 1218-2965; Email: stroh@dhm.mhn.de
    • Principal Investigator: Sabine Bleiziffer, MD
    • Sub-Investigator: Getrud Goppel, MD
• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
    • Contact: Vega Rusconi; Phone Number: +39 022 643 7362; Email: Rusconi.vega@hsr.it
    • Sub-Investigator: Eustachio Agricola, MD
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
    • Contact: Chiara Primerano; Phone Number: +39 050099 5326; Email: chiaraprim@gmail.com
    • Principal Investigator: Sonia Petronio, MD
    • Sub-Investigator: Paolo Spontoni, MD
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Not yet recruiting
    • Amphia Ziekenhuis
    • Contact: Manola Smits; Phone Number: +31765955100; Email: MSmits1@amphia.nl
    • Principal Investigator: Peter den Heijer, MD
    • Sub-Investigator: BJL van den Branden, MD
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Greetje de Jong; Phone Number: +31 50 361 3348; Email: g.h.de.jong@umcg.nl
    • Principal Investigator: AFM van den Heuvel, MD
    • Principal Investigator: P van der Harst, MD
• Portugal
  • Porto, Portugal
    • Recruiting
    • C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
    • Contact: Sonia M Dias; Phone Number: +351 934361674; Email: sdias@CHVNG.MIN-SAUDE.PT
    • Principal Investigator: Vasco Da Gama, MD
    • Sub-Investigator: Jose Braga, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
• ≥18 and ≤85 years old;
• NYHA II, III, or ambulatory IV;
• Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
• patient is at high risk for open heart valve surgery
• LVEF ≥35%
• Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2)

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Open Label; Non-randomized, open label clinical study that intends to treat up to 60 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.

Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS); Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all-cause mortality at 30 days.	Incidence of all-cause mortality at 30 days.	30-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success, defined as freedom from death at 30 days with: successful access, delivery and retrieval of the device delivery system;; deployment and correct positioning of the intended device(s) which is maintained and;; no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure	30 Days
Echocardiographic variable: tenting height (maximum, any view)	Echocardiographic variables assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Echocardiographic variable: tenting area (maximum, any view)	Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)	Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Tricuspid regurgitation as determined by echocardiographic methods	As measured by the PISA method and the Quantitative Flow method	Change from Baseline at 30 days
Percent tricuspid regurgitation from baseline to 30-days	Percent tricuspid regurgitation from baseline to 30-days	Change from Baseline at 30 days
Adverse Events	Rate of adverse events, including serious adverse events	Up to 60 months post procedure
New York Heart Association (NYHA) classification	Change in New York Heart Association (NYHA) classification	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Six-Minute Walk Test (6MWT)	Change in the Six-Minute Walk Test (6MWT)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Minnesota Living with Heart Failure Questionnaire (MLWHF)	Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
EuroQol Five Dimensions Questionnaire (EQ-5D)	Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure

Collaborators and Investigators

• Sponsor: Mitralign, Inc.
• Collaborators: CardioVascular Research Foundation, Korea; Regulatory and Clinical Research Institute Inc; Genae
• Investigators: Principal Investigator: Prof. Dr. med Joachim Schofer, Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CLPR-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes