Clinical trial NCT03632967: Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Official title: Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Tricuspid Regurgitation
Heart Valve Diseases
Tricuspid Valve Insufficiency
Lead sponsor: 4Tech Cardio Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: All-cause mortality of the Per Protocol cohort at 30 days post procedure.
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Number of individual adverse events related to the system or procedure.
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Exercise tolerance (Six Minute Walk Test)
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
measure: Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
timeFrame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Thousand Oaks
country: United States
facility: HCA Research Institute at Los Robles Hospital & Medical Center
state: California
city: Atlanta
country: United States
facility: Piedmont Heart Hospital
state: Georgia
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Minneapolis
country: United States
facility: Abbott Northwestern - Minneapolis Heart Institute
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Plano
country: United States
facility: Baylor Plano Heart Hospital
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: