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

February 6, 2018 updated by: Mitralign, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum am Urban
        • Contact:
        • Sub-Investigator:
          • Hueseyin Ince, MD
        • Principal Investigator:
          • Stephan Kische, MD
      • Bernau bei Berlin, Germany, 16321
        • Recruiting
        • Herzzentrum Brandenburg in Bernau
        • Contact:
        • Principal Investigator:
          • Christian Butter, MD
        • Sub-Investigator:
          • Michael Neuss, MD
      • Frankfurt, Germany, 60389
        • Recruiting
        • Cardiovascular center Frankfurt
        • Contact:
        • Sub-Investigator:
          • Markus Reinartz, MD
      • Hamburg, Germany, 22527
        • Recruiting
        • Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
        • Contact:
        • Principal Investigator:
          • Joachim Schofer, MD
        • Sub-Investigator:
          • Claudia Tiburtius, MD
      • Leipzig, Germany, 04289
        • Recruiting
        • Herzzentrum Leipzig - Universitätsklinik
        • Contact:
        • 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:
        • Sub-Investigator:
          • Eustachio Agricola, MD
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
        • Principal Investigator:
          • Sonia Petronio, MD
        • Sub-Investigator:
          • Paolo Spontoni, MD
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Not yet recruiting
        • Amphia Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Peter den Heijer, MD
        • Sub-Investigator:
          • BJL van den Branden, MD
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • 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:
        • Principal Investigator:
          • Vasco Da Gama, MD
        • Sub-Investigator:
          • Jose Braga, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of all-cause mortality at 30 days.
Time Frame: 30-days
Incidence of all-cause mortality at 30 days.
30-days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 30 Days

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)
Time Frame: Change from Baseline at 30 days
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)
Time Frame: Change from Baseline at 30 days
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)
Time Frame: Change from Baseline at 30 days
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
Time Frame: Change from Baseline at 30 days
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
Time Frame: Change from Baseline at 30 days
Percent tricuspid regurgitation from baseline to 30-days
Change from Baseline at 30 days
Adverse Events
Time Frame: Up to 60 months post procedure
Rate of adverse events, including serious adverse events
Up to 60 months post procedure
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
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)
Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
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)
Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
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)
Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mitralign, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea
Regulatory and Clinical Research Institute Inc
Genae

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Dr. med Joachim Schofer, Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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