Back to resultsEarly Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Primary Purpose
Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tricinch Coil System Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Functional Tricuspid Regurgitation
Eligibility Criteria
Inclusion Criteria:
- 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
- Major of age( ≥ 18 years old or older per local regulation)
- Subject has read and signed the informed consent prior to study related procedures.
- Willing and able to comply with all required follow-up evaluations and assessments.
- The 'Heart Team' assessment recommends TriCinch Coil Implantation
- New York Heart Associate Classification ≥ II.
- Left Ventricular Ejection Fraction ≥ 30%.
- 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
- Subject has suitable anatomy for investigational device implantation as per imaging requirements
Exclusion Criteria:
- Currently participating in another investigational drug or device study.
- Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
- 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
- Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
- Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
- Mitral stenosis and/or regurgitation more than moderate
- Intra-cardiac thrombus, mass or vegetation requiring active treatment.
- Implanted inferior vena cava (IVC) filter.
- Prior tricuspid repair or tricuspid replacement
- Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
- History of cardiac transplantation
- Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
- Endocarditis or severe infection within 12 months of scheduled implant procedure
- Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
- Cerebro Vascular Accident within the previous 6 months
- Hemodynamic instability or on IV inotropes
- Contraindication to anticoagulant therapy and antiplatelet therapy
- Bleeding disorders or hypercoagulable condition (at risk of blood clots
- Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
- Severe renal impairment or on dialysis
- Life expectancy less than 12 months.
- Acute anemia
- Chronic Oral Steroid Use ≥ 6 months
- Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- Pulmonary embolism within the last 6 months
- Tricuspid Valve Tethering distance > 10 mm
- Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
- Contra-indicated for blood transfusion or refuses transfusion
- Patient undergoing emergency treatment
- Patient without appropriate venous access
Sites / Locations
- Cedars Sinai Medical Center
- HCA Research Institute at Los Robles Hospital & Medical Center
- Piedmont Heart Hospital
- Cardiovascular Institute of the South
- Abbott Northwestern - Minneapolis Heart Institute
- Columbia University Medical Center/NYPH
- Houston Methodist
- Baylor Plano Heart Hospital
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device: TriCinch Coil System treatment
Arm Description
Outcomes
Primary Outcome Measures
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Secondary Outcome Measures
Number of individual adverse events related to the system or procedure.
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
as assessed by the flow convergence method
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).
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Exercise tolerance (Six Minute Walk Test)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03632967
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
as per sponsor
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4Tech Cardio Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device: TriCinch Coil System treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tricinch Coil System Implantation
Intervention Description
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 Measure Information:
Title
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
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
Title
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
Description
as assessed by the flow convergence method
Time Frame
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Title
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
Description
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).
Time Frame
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Title
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
Title
Exercise tolerance (Six Minute Walk Test)
Time Frame
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Title
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Description
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.
Time Frame
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Major of age( ≥ 18 years old or older per local regulation)
Subject has read and signed the informed consent prior to study related procedures.
Willing and able to comply with all required follow-up evaluations and assessments.
The 'Heart Team' assessment recommends TriCinch Coil Implantation
New York Heart Associate Classification ≥ II.
Left Ventricular Ejection Fraction ≥ 30%.
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
Subject has suitable anatomy for investigational device implantation as per imaging requirements
Exclusion Criteria:
Currently participating in another investigational drug or device study.
Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
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
Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
Mitral stenosis and/or regurgitation more than moderate
Intra-cardiac thrombus, mass or vegetation requiring active treatment.
Implanted inferior vena cava (IVC) filter.
Prior tricuspid repair or tricuspid replacement
Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
History of cardiac transplantation
Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
Endocarditis or severe infection within 12 months of scheduled implant procedure
Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
Cerebro Vascular Accident within the previous 6 months
Hemodynamic instability or on IV inotropes
Contraindication to anticoagulant therapy and antiplatelet therapy
Bleeding disorders or hypercoagulable condition (at risk of blood clots
Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
Severe renal impairment or on dialysis
Life expectancy less than 12 months.
Acute anemia
Chronic Oral Steroid Use ≥ 6 months
Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
Pulmonary embolism within the last 6 months
Tricuspid Valve Tethering distance > 10 mm
Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
Contra-indicated for blood transfusion or refuses transfusion
Patient undergoing emergency treatment
Patient without appropriate venous access
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
HCA Research Institute at Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Piedmont Heart Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Abbott Northwestern - Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Plano Heart Hospital
City
Plano
State/Province
Texas
ZIP/Postal Code
75205
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
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