Functional Tricuspid RegurgitationNCT03632967
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
A study testing Tricinch Coil System Implantation in people with Functional Tricuspid Regurgitation and Heart Valve Diseases, run by 4Tech Cardio Ltd. at 9 sites in United States.
Trial summary
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- What is being tested?
- Tricinch Coil System Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Sep 2018to 14 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color flow doppler evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography
- Major of age( ≥ 18 years old or older per local regulation)
- Subject has read and signed the informed consent prior to study related procedures.
- Willing and able to comply with all required follow-up evaluations and assessments.
- The 'Heart Team' assessment recommends TriCinch Coil Implantation
- New York Heart Associate Classification ≥ II.
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- Left Ventricular Ejection Fraction ≥ 30%.
- Heart failure symptoms (such as fluid retention and severe oedema, liver stasis) despite on optimized medical therapy by the local heart team; at minimum subject on diuretic use
- Subject has suitable anatomy for investigational device implantation as per imaging requirements
Who cannot join
- Currently participating in another investigational drug or device study.
- Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
- Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
- Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
- Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
- Mitral stenosis and/or regurgitation more than moderate
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- Intra-cardiac thrombus, mass or vegetation requiring active treatment.
- Implanted inferior vena cava (IVC) filter.
- Prior tricuspid repair or tricuspid replacement
- Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
- History of cardiac transplantation
- Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
- Endocarditis or severe infection within 12 months of scheduled implant procedure
- Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
- Cerebro Vascular Accident within the previous 6 months
- Hemodynamic instability or on IV inotropes
- Contraindication to anticoagulant therapy and antiplatelet therapy
- Bleeding disorders or hypercoagulable condition (at risk of blood clots
- Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
- Severe renal impairment or on dialysis
- Life expectancy less than 12 months.
- Acute anemia
- Chronic Oral Steroid Use ≥ 6 months
- Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- Pulmonary embolism within the last 6 months
- Tricuspid Valve Tethering distance > 10 mm
- Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
- Contra-indicated for blood transfusion or refuses transfusion
- Patient undergoing emergency treatment
- Patient without appropriate venous access
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Piedmont Heart Hospital
Atlanta, Georgia, 30309
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Houston Methodist
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
Abbott Northwestern - Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Columbia University Medical Center/NYPH
New York, New York, 10032
Baylor Plano Heart Hospital
Plano, Texas, 75205
University of Washington Medical Center
Seattle, Washington, 98195
HCA Research Institute at Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
About this study
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation.
The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
- Being tested
- Tricinch Coil System Implantation
- Medical subject headings
- Heart Valve Diseases, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricinch Coil System ImplantationDevice
Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve.
| Study group | Role | What they receive |
|---|---|---|
| Device: TriCinch Coil System treatment | Experimental | Not described Receives: Device: Tricinch Coil System Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Measured: 30 days post procedure
Secondary outcomes (6)
Number of individual adverse events related to the system or procedure.
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
as assessed by the flow convergence method
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
The severity of patients' heart failure symptoms is assessed using the New York Heart Association (NYHA) classification. Patients are ranked from Class I (no limitation of physical activity) to Class IV (unable to carry on any physical activity without discomfort).
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Exercise tolerance (Six Minute Walk Test)
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: 30 days, three (3), six (6), twelve (12) and twenty-four (24) 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 posted16 Aug 2018
- Study start12 Sep 2018
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Why it stopped: as per sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Tech Cardio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632967
- Sponsor's protocol ID
- CIP 2102-01
- Status last verified
- Jul 2020
- First submitted
- 9 Aug 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
- ClinicalTrials.gov ID
- NCT03632967
- Acronym / sponsor ID
- CIP 2102-01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: as per sponsor
- Enrolment
- 7 participants (actual)
- Lead sponsor
- 4Tech Cardio Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 16 Aug 2018 (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 primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation.
The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: TriCinch Coil System treatment | Experimental | Device: Tricinch Coil System Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color flow doppler evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography
- Major of age( ≥ 18 years old or older per local regulation)
- Subject has read and signed the informed consent prior to study related procedures.
- Willing and able to comply with all required follow-up evaluations and assessments.
- The 'Heart Team' assessment recommends TriCinch Coil Implantation
Key exclusion criteria (30 listed)
- Currently participating in another investigational drug or device study.
- Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
- Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
- Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
- Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
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 |
|---|---|---|
| Tricinch Coil System ImplantationPatients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve. | Device | Device: TriCinch Coil System treatment |
Primary outcome
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Time frame: 30 days post procedure
6 secondary outcomes
Number of individual adverse events related to the system or procedure.
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Exercise tolerance (Six Minute Walk Test)
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Results and safety
The study was stopped early (reason given: as per sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricinch Coil System Implantation in people with Functional Tricuspid Regurgitation and Heart Valve Diseases, run by 4Tech Cardio Ltd. at 9 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 9 inclusion and 30 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: stopped early, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study was stopped early (reason given: as per sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality of the Per Protocol cohort at 30 days post procedure. (time frame: 30 days post procedure). 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 31 Jul 2020; AzTrials last refreshed its copy on 26 Oct 2026.