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

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03632967
• Other study ID #: CIP 2102-01
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2020
• Source: 4Tech Cardio Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Heart Valve Diseases
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Heart Hospital	Atlanta	Georgia
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Houston Methodist	Houston	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Abbott Northwestern - Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Baylor Plano Heart Hospital	Plano	Texas
United States	University of Washington Medical Center	Seattle	Washington
United States	HCA Research Institute at Los Robles Hospital & Medical Center	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
4Tech Cardio Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality of the Per Protocol cohort at 30 days post procedure.		30 days post procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Exercise tolerance (Six Minute Walk Test)		30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Secondary	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