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Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632967
Recruitment Status : Terminated (as per sponsor)
First Posted : August 16, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
4Tech Cardio Ltd.

Brief 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.

The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.


Condition or disease Intervention/treatment Phase
Functional Tricuspid Regurgitation Heart Valve Diseases Tricuspid Valve Insufficiency Device: Tricinch Coil System Implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : July 14, 2020
Actual Study Completion Date : July 14, 2020

Arm Intervention/treatment
Experimental: Device: TriCinch Coil System treatment Device: Tricinch Coil System Implantation
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.




Primary Outcome Measures :
  1. All-cause mortality of the Per Protocol cohort at 30 days post procedure. [ Time Frame: 30 days post procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    as assessed by the flow convergence method

  3. 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 ]
    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).

  4. 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 ]
  5. Exercise tolerance (Six Minute Walk Test) [ Time Frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure ]
  6. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Major of age( ≥ 18 years old or older per local regulation)
  3. Subject has read and signed the informed consent prior to study related procedures.
  4. Willing and able to comply with all required follow-up evaluations and assessments.
  5. The 'Heart Team' assessment recommends TriCinch Coil Implantation
  6. New York Heart Associate Classification ≥ II.
  7. Left Ventricular Ejection Fraction ≥ 30%.
  8. 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
  9. Subject has suitable anatomy for investigational device implantation as per imaging requirements

Exclusion Criteria:

  1. Currently participating in another investigational drug or device study.
  2. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
  3. 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
  4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
  5. Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
  6. Mitral stenosis and/or regurgitation more than moderate
  7. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
  8. Implanted inferior vena cava (IVC) filter.
  9. Prior tricuspid repair or tricuspid replacement
  10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
  11. History of cardiac transplantation
  12. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
  13. Endocarditis or severe infection within 12 months of scheduled implant procedure
  14. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
  15. Cerebro Vascular Accident within the previous 6 months
  16. Hemodynamic instability or on IV inotropes
  17. Contraindication to anticoagulant therapy and antiplatelet therapy
  18. Bleeding disorders or hypercoagulable condition (at risk of blood clots
  19. Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
  20. Severe renal impairment or on dialysis
  21. Life expectancy less than 12 months.
  22. Acute anemia
  23. Chronic Oral Steroid Use ≥ 6 months
  24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
  25. Pulmonary embolism within the last 6 months
  26. Tricuspid Valve Tethering distance > 10 mm
  27. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
  28. Contra-indicated for blood transfusion or refuses transfusion
  29. Patient undergoing emergency treatment
  30. Patient without appropriate venous access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632967


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
HCA Research Institute at Los Robles Hospital & Medical Center
Thousand Oaks, California, United States, 91360
United States, Georgia
Piedmont Heart Hospital
Atlanta, Georgia, United States, 30309
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Minnesota
Abbott Northwestern - Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
Baylor Plano Heart Hospital
Plano, Texas, United States, 75205
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
4Tech Cardio Ltd.
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Responsible Party: 4Tech Cardio Ltd.
ClinicalTrials.gov Identifier: NCT03632967    
Other Study ID Numbers: CIP 2102-01
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases