Chronic Symptomatic Functional Tricuspid RegurgitationSCOUT-IINCT03225612
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
A study testing Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) in people with Chronic Symptomatic Functional Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by Mitralign, Inc. at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- What is being tested?
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 22 May 2017to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany6 sites, 6 recruiting
- Recruiting
Vivantes Klinikum Am Urban
Berlin, 10967
Maria Schuppe, +49 030 130 22 5101, maria.schuppe@vivantes.de
Hueseyin Ince, MD
- Recruiting
Herzzentrum Brandenburg in Bernau
Bernau bei Berlin, 16321
Daniela Bettin, +49 33 3869 4604, d.bettin@immanuel.de
Christian Butter, MD
- Recruiting
CardioVascular Center Frankfurt
Frankfurt, 60389
Sabine de Bruijn, +49 69 9794 7653, s.debruijn@cvcfrankfurt.de
Horst Sievert, MD
- Recruiting
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg, 22527
Stefanie Bohme, +49 40 889006 830, Boehme@herz-hh.de
Joachim Schofer, MD
- Recruiting
Herzzentrum Leipzig - Universitätsklinik
Leipzig, 04289
Anne Kathrin Funkat, +49 341 865 1587, Anne-kathrin.funkat@leipzig-heart.de
Philipp Lurz, MD
- Recruiting
German Heart Center Munich
Munich, 80636
Annemarie Stroh, PhD, +49 (0) 89 1218-2965, stroh@dhm.mhn.de
Sabine Bleiziffer, MD
Italy2 sites, 2 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
Vega Rusconi, +39 022 643 7362, Rusconi.vega@hsr.it
Azeem Latib, MD
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Chiara Primerano, +39 050099 5326, chiaraprim@gmail.com
Sonia Petronio, MD
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Amphia Ziekenhuis
Breda, 4818 CK
Manola Smits, +31765955100, MSmits1@amphia.nl
Peter den Heijer, MD
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Greetje de Jong, +31 50 361 3348, g.h.de.jong@umcg.nl
AFM van den Heuvel, MD
Portugal1 site, 1 recruiting
- Recruiting
C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
Porto
Sonia M Dias, +351 934361674, sdias@CHVNG.MIN-SAUDE.PT
Vasco Da Gama, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Being tested
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | 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. Receives: Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-cause mortality at 30 days.
Incidence of all-cause mortality at 30 days.
Measured: 30-days
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at 30 days
Tricuspid regurgitation as determined by echocardiographic methods
As measured by the PISA method and the Quantitative Flow method
Measured: Change from Baseline at 30 days
Percent tricuspid regurgitation from baseline to 30-days
Percent tricuspid regurgitation from baseline to 30-days
Measured: Change from Baseline at 30 days
Adverse Events
Rate of adverse events, including serious adverse events
Measured: Up to 60 months post procedure
New York Heart Association (NYHA) classification
Change in New York Heart Association (NYHA) classification
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start22 May 2017
- Primary completionJun 2018 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Symptomatic Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitralign, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genae, Regulatory and Clinical Research Institute Inc, CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med Joachim Schofer, Principal investigator, Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225612
- Sponsor's protocol ID
- CLPR-011
- Acronym
- SCOUT-II
- Status last verified
- Feb 2018
- First submitted
- 14 Jun 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT03225612
- Acronym / sponsor ID
- SCOUT-II / CLPR-011
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mitralign, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genae, Regulatory and Clinical Research Institute Inc, CardioVascular Research Foundation, Korea
- Study start
- 22 May 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Open Label |
Primary outcome
Incidence of all-cause mortality at 30 days.
Time frame: 30-days
Incidence of all-cause mortality at 30 days.
11 secondary outcomes
Technical success
Time frame: 30 Days
Echocardiographic variable: tenting height (maximum, any view)
Time frame: Change from Baseline at 30 days
Echocardiographic variable: tenting area (maximum, any view)
Time frame: 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
Tricuspid regurgitation as determined by echocardiographic methods
Time frame: Change from Baseline at 30 days
Percent tricuspid regurgitation from baseline to 30-days
Time frame: Change from Baseline at 30 days
Adverse Events
Time frame: 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Symptomatic Functional Tricuspid Regurgitation
Active, not recruitingObservational study
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
Tricuspid Regurgitation, Tricuspid Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. med Joachim Schofer principal investigator
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) in people with Chronic Symptomatic Functional Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by Mitralign, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Netherlands, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Keating (978-863-2445, pkeating@mitralign.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-cause mortality at 30 days. (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.