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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Sponsored by
Mitralign, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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, 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

Sites / Locations

  • Vivantes Klinikum Am UrbanRecruiting
  • Herzzentrum Brandenburg in BernauRecruiting
  • CardioVascular Center FrankfurtRecruiting
  • Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbHRecruiting
  • Herzzentrum Leipzig - UniversitätsklinikRecruiting
  • German Heart Center MunichRecruiting
  • Ospedale San RaffaeleRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Amphia Ziekenhuis
  • University Medical Center GroningenRecruiting
  • C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.Recruiting

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 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.

Outcomes

Primary Outcome Measures

Incidence of all-cause mortality at 30 days.
Incidence of all-cause mortality at 30 days.

Secondary Outcome Measures

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
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
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
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
Tricuspid regurgitation as determined by echocardiographic methods
As measured by the PISA method and the Quantitative Flow method
Percent tricuspid regurgitation from baseline to 30-days
Percent tricuspid regurgitation from baseline to 30-days
Adverse Events
Rate of adverse events, including serious adverse events
New York Heart Association (NYHA) classification
Change in New York Heart Association (NYHA) classification
Six-Minute Walk Test (6MWT)
Change in the Six-Minute Walk Test (6MWT)
Minnesota Living with Heart Failure Questionnaire (MLWHF)
Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)
EuroQol Five Dimensions Questionnaire (EQ-5D)
Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)

Full Information

First Posted
June 14, 2017
Last Updated
February 6, 2018
Sponsor
Mitralign, Inc.
Collaborators
Genae, Regulatory and Clinical Research Institute Inc, CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03225612
Brief Title
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Acronym
SCOUT-II
Official Title
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitralign, Inc.
Collaborators
Genae, Regulatory and Clinical Research Institute Inc, CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of all-cause mortality at 30 days.
Description
Incidence of all-cause mortality at 30 days.
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Technical success
Description
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
Time Frame
30 Days
Title
Echocardiographic variable: tenting height (maximum, any view)
Description
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
Time Frame
Change from Baseline at 30 days
Title
Echocardiographic variable: tenting area (maximum, any view)
Description
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
Time Frame
Change from Baseline at 30 days
Title
Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)
Description
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
Time Frame
Change from Baseline at 30 days
Title
Tricuspid regurgitation as determined by echocardiographic methods
Description
As measured by the PISA method and the Quantitative Flow method
Time Frame
Change from Baseline at 30 days
Title
Percent tricuspid regurgitation from baseline to 30-days
Description
Percent tricuspid regurgitation from baseline to 30-days
Time Frame
Change from Baseline at 30 days
Title
Adverse Events
Description
Rate of adverse events, including serious adverse events
Time Frame
Up to 60 months post procedure
Title
New York Heart Association (NYHA) classification
Description
Change in New York Heart Association (NYHA) classification
Time Frame
Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Title
Six-Minute Walk Test (6MWT)
Description
Change in the Six-Minute Walk Test (6MWT)
Time Frame
Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Title
Minnesota Living with Heart Failure Questionnaire (MLWHF)
Description
Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)
Time Frame
Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Title
EuroQol Five Dimensions Questionnaire (EQ-5D)
Description
Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)
Time Frame
Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Keating
Phone
978-863-2445
Email
pkeating@mitralign.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gisella Blanchette
Phone
978.863.2435
Email
gblanchette@mitralign.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. med Joachim Schofer
Organizational Affiliation
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Schuppe
Phone
+49 030 130 22 5101
Email
maria.schuppe@vivantes.de
First Name & Middle Initial & Last Name & Degree
Hueseyin Ince, MD
First Name & Middle Initial & Last Name & Degree
Stephan Kische, MD
Facility Name
Herzzentrum Brandenburg in Bernau
City
Bernau bei Berlin
ZIP/Postal Code
16321
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Bettin
Phone
+49 33 3869 4604
Email
d.bettin@immanuel.de
First Name & Middle Initial & Last Name & Degree
Christian Butter, MD
First Name & Middle Initial & Last Name & Degree
Michael Neuss, MD
Facility Name
CardioVascular Center Frankfurt
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine de Bruijn
Phone
+49 69 9794 7653
Email
s.debruijn@cvcfrankfurt.de
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
First Name & Middle Initial & Last Name & Degree
Markus Reinartz, MD
Facility Name
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefanie Bohme
Phone
+49 40 889006 830
Email
Boehme@herz-hh.de
First Name & Middle Initial & Last Name & Degree
Joachim Schofer, MD
First Name & Middle Initial & Last Name & Degree
Claudia Tiburtius, MD
Facility Name
Herzzentrum Leipzig - Universitätsklinik
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Kathrin Funkat
Phone
+49 341 865 1587
Email
Anne-kathrin.funkat@leipzig-heart.de
First Name & Middle Initial & Last Name & Degree
Philipp Lurz, MD
First Name & Middle Initial & Last Name & Degree
Joerg Seeburger, MD
Facility Name
German Heart Center Munich
City
Munich
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemarie Stroh, PhD
Phone
+49 (0) 89 1218-2965
Email
stroh@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Sabine Bleiziffer, MD
First Name & Middle Initial & Last Name & Degree
Getrud Goppel, MD
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vega Rusconi
Phone
+39 022 643 7362
Email
Rusconi.vega@hsr.it
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
First Name & Middle Initial & Last Name & Degree
Eustachio Agricola, MD
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Primerano
Phone
+39 050099 5326
Email
chiaraprim@gmail.com
First Name & Middle Initial & Last Name & Degree
Sonia Petronio, MD
First Name & Middle Initial & Last Name & Degree
Paolo Spontoni, MD
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manola Smits
Phone
+31765955100
Email
MSmits1@amphia.nl
First Name & Middle Initial & Last Name & Degree
Peter den Heijer, MD
First Name & Middle Initial & Last Name & Degree
BJL van den Branden, MD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greetje de Jong
Phone
+31 50 361 3348
Email
g.h.de.jong@umcg.nl
First Name & Middle Initial & Last Name & Degree
AFM van den Heuvel, MD
First Name & Middle Initial & Last Name & Degree
P van der Harst, MD
Facility Name
C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia M Dias
Phone
+351 934361674
Email
sdias@CHVNG.MIN-SAUDE.PT
First Name & Middle Initial & Last Name & Degree
Vasco Da Gama, MD
First Name & Middle Initial & Last Name & Degree
Jose Braga, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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