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

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 Overview

• Status: Terminated
• Conditions: Heart Valve Diseases; Tricuspid Valve Insufficiency; Functional Tricuspid Regurgitation
• Intervention / Treatment: Device: Tricinch Coil System Implantation

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Thousand Oaks, California, United States, 91360
      • HCA Research Institute at Los Robles Hospital & Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern - Minneapolis Heart Institute
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Plano, Texas, United States, 75205
      • Baylor Plano Heart Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality of the Per Protocol cohort at 30 days post procedure.	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of individual adverse events related to the system or procedure.		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	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).	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		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Exercise tolerance (Six Minute Walk Test)		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.	30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure

Collaborators and Investigators

• Sponsor: 4Tech Cardio Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2018
• Primary Completion (ACTUAL): July 14, 2020
• Study Completion (ACTUAL): July 14, 2020

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CIP 2102-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes