Chronic Symptomatic Functional Tricuspid RegurgitationSCOUTNCT02574650
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
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 United States.
Trial 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). 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
- 30 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to May 2019
- 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 - 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))
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 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Christopher Meduri, MD, 404-605-6517, christopher.meduri@piedmont.org
Christopher Meduri, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Scott Lim, MD, 434-982-1058, sl9pc@virginia.edu
Scott Lim, MD
- Recruiting
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, 60611
Stuart Rich, MD, 312-695-9979, srich@nm.org
Stuart Rich, MD
- Recruiting
Delray Medical Center
Delray Beach, Florida, 33484
Laura Hudson, 561-495-3145, Laura.Hudson@tenethealth.com
Brijeshwar Maini, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Lisa Green, LMGreen@houstonmethodist.org
Colin Baker, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Saibal Kar, MD, 310-423-3977, saibal.kar2@cshs.org
Saibal Kar, MD
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Karen Meyer, Karen.Meyer2@allina.com
Mario Goessl, MD, PhD
- Recruiting
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, 10032
Rebecca Hahn, MD, 212-305-7060, rth2@cumc.columbia.edu
Rebecca Hahn, MD
- Recruiting
Kaiser Permanente
San Francisco, California, 94115
Cristina Casias, RN, CCRC, 415-833-3480, Cristina.Casias@kp.org
Andrew Rassi, MD
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Andrea Drouhard, Andrea.Drouhard@swedish.org
Sameer Gafoor, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lowell Satler, MD, 202-877-5975, satlerlowell@gmail.com
Lowell Satler, MD
About this study
Official title: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
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.
Read the detailed description
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-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) delivered by a percutaneous transcatheter procedure.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | 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. 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.
Technical success at 30-days
Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
Measured: 30-days
Secondary outcomes (2)
Secondary safety and performance endpoints mid-term and long-term
The secondary objectives of the study are to evaluate the acute, mid-term and long-term safety of the device and effects of the device on performance, functional and quality of life parameters, as well as technical, procedural and individual patient successes.
Measured: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked
Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated.
Measured: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitralign, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Hahn, MD, Principal investigator, Columbia Unviersity Medical Center / New York-Presbyterian HospitalChristopher Meduri, MD, MPH, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574650
- Sponsor's protocol ID
- CLPR-010
- Acronym
- SCOUT
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hahn RT, Meduri CU, Davidson CJ, Lim S, Nazif TM, Ricciardi MJ, Rajagopal V, Ailawadi G, Vannan MA, Thomas JD, Fowler D, Rich S, Martin R, Ong G, Groothuis A, Kodali S. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.
PubMed 28385308
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT02574650
- Acronym / sponsor ID
- SCOUT / CLPR-010
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mitralign, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 14 Oct 2015 (estimated)
- 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 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.
Detailed description
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-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 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
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) delivered by a percutaneous transcatheter procedure. | Device | Open Label |
Primary outcome
Technical success at 30-days
Time frame: 30-days
Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
2 secondary outcomes
Secondary safety and performance endpoints mid-term and long-term
Time frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked
Time frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 28385308Hahn RT, Meduri CU, Davidson CJ, Lim S, Nazif TM, Ricciardi MJ, Rajagopal V, Ailawadi G, Vannan MA, Thomas JD, Fowler D, Rich S, Martin R, Ong G, Groothuis A, Kodali S. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.
- 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.
Rebecca Hahn, MD principal investigator
Columbia Unviersity Medical Center / New York-Presbyterian Hospital
Christopher Meduri, MD, MPH principal investigator
Piedmont Healthcare
11 sites in 1 country: 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 United States.
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 6 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 27 Oct 2017. 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 United States. 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 Gisella Blanchette (978-863-2435, gblanchette@mitralign.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success 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?
On the ClinicalTrials.gov record for NCT02574650, which also lists 1 linked publication.
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 27 Oct 2017.