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

Not Applicable

Terminated

• Conditions: Tricuspid Valve Insufficiency; Heart Valve Diseases; Functional Tricuspid Regurgitation
• Interventions: Device: Tricinch Coil System Implantation

• Registration Number: NCT03632967
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Study Start: 2018-09-12
• Status Verified: 2020-07
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: TriCinch Coil System treatment	Tricinch Coil System Implantation	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality of the Per Protocol cohort at 30 days post procedure.	30 days post procedure

Secondary Outcome Measures

Name	Time	Method
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	30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure	as assessed by the flow convergence method
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification	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).
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).	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.
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

Trial Locations

Locations (9)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Columbia University Medical Center/NYPH; 🇺🇸 New York, New York, United States

Abbott Northwestern - Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

HCA Research Institute at Los Robles Hospital & Medical Center; 🇺🇸 Thousand Oaks, California, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Baylor Plano Heart Hospital; 🇺🇸 Plano, Texas, United States

Piedmont Heart Hospital; 🇺🇸 Atlanta, Georgia, United States