4. CTP-2102-04, Rev 01_TriCinch Coil FIH Protocol

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TriCinch Coil System Protocol

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Feasibility Study Design

Study Design:

Clinical feasibility safety and performance study, multi-center, prospective, single-arm, non-randomized study

Study Objectives:

Evaluate feasibility safety and performance for the 4Tech TriCinch Coil System

Study Centers :

Up to 7 centers Australia & Europe

Study Population:

TriCinch Coil System is intended to repair and/or reconstruct pathological tricuspid valves in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation

Number of Subjects:

 ≤ 44 patients total (2 max. roll-in per site)

Study Period:

Approx. 18 months (6 month enrolment + 12 month follow-up)

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Primary Endpoints

  • Primary Safety at 30 days

All-cause mortality of the per-protocol cohort at 30 days post procedure

  • Primary Performance at 30 days

Successful access, deployment and positioning of the TriCinch Coil device and sept lateral reduction between baseline and 30 days

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Secondary Endpoints

  • Safety: Individual adverse events related to the system or procedure at 30 days, 3, 6 and 12 months
  • Echo improvement: at 30 days, 3, 6 and 12 months by means of echo semi & quantitative measures (e.g. TV annular diameter, TV area, vena contracta, PISA EROA, Quantitative EROA, TV Regurgitant Volume, RA, RV, IVC dimensions).
  • Functional Improvement: at 30 days, 3, 6 and 12 months for New York Heart Association (NYHA) classification, Six Minute Walk Test and QOL evaluation (Kansas City Cardiomyopathy Questionnaire).
  • Heart Failure Rate: post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent

Observational Endpoints

  • Kidney function
  • Diuretics
  • Radiation dose during the procedure

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Study Flow

Med History + Echo (TTE)

Signed Informed Consent

Not Eligible

Study Termination

CT Scan Review

Not Eligible

Study Termination

Baseline Visit

Implantation

TriCinch Coil System

Unsuccessful

Hospitalization + Discharge

Hospitalization + Discharge

Safety Follow-Up: 30 Days

Follow-up:

30D, 3, 6 & 12 months

Study Termination

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Inclusion Criteria

  • Functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm
  • ≥ 18 years old
  • 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%.
  • Symptomatic 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

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Exclusion Criteria

  • Currently participating in another investigational drug or device study.
  • Pulmonary arterial pressure (sPAP) > 60mmHg
  • 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
  • Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate
  • Intra-cardiac thrombus, mass or vegetation.
  • Implanted inferior vena cava (IVC) filter.
  • Prior tricuspid repair/replacement
  • Allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol
  • History of cardiac transplantation
  • Contraindication to TTE/TOE*
  • Endocarditis or severe infection within 3 months of scheduled implant procedure
  • Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure

*Transthoracic/Transoesophageal Echocardiography

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Exclusion Criteria (Continued)

  • Cerebro Vascular Accident within the previous 6 months
  • Hemodynamic instability or on IV inotropes
  • Contraindication to anticoagulant therapy or dual antiplatelet therapy
  • Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal 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

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Screening and Baseline

P r oce dur e

Hos pitaliza tion

Discharge

Safety

30 days

30

Days

90

Days

6

Months

12

months

Add al Visits

Visit Numbe r

1

2

3

4

4

5

6

7

N/A

Range from the index procedure

-30 days

- 7 days

0

Up to 7 days

+/- 7

Days

+/- 7

Days

+/- 7

Days

180 +/- 14 days

365 +/- 30 days

N/A

Informed Consent Form

X

 

 

 

 

 

 

 

 

 

CT Scan

X

 

 

 

 

 

 

 

 

 

Demographics and Medical History

X

 

 

 

 

 

 

 

 

 

STS, EuroScore II

X

 

 

 

 

 

 

 

 

 

Blood tests

 

X

 

X

X

X

X

X

X

X

Clinical Enzyme test

 

 

 

X*

 

 

 

 

 

 

Implant procedure (including RA catheterization and Intra Cardiac Echo Guidance)

 

 

X

 

 

 

 

 

 

 

General Clinical State

X

 

 

X

X

X

X

X

X

X

Acute Transthoracic Echo post procedure

 

 

 

X**

 

 

 

 

 

 

Deviations, Adverse Events & Device Deficiencies

X

X

X

X

X

X

X

X

X

X

Cardiac Medication Profile

X

 

 

X

X

X

X

X

X

X

Pregnancy Test

(if applicable)

 

X

 

 

 

 

 

 

 

 

ECG

 

X

X

X

X

X

X

X

X

X

Tricuspid Regurgitation Assessment by TTE

X

 

 

X

 

X

X

X

X

X

Tricuspid Regurgitation Assessment by TOE

 

 

X

 

 

 

 

 

 

 

NYHA Functional Class

X

X

 

 

 

X

X

X

X

X

QoL Questionnaire (KCCQ)

 

X

 

 

 

X

X

X

X

 

6 Minute Walk Test

 

X

 

 

 

X

X

X

X

 

X ray

 

 

 

 

 

X

 

X***

 

 

NOTES: *Clinical Enzyme tests performed twice: at 6-8h and 12-16 hours post-procedure; ** A TTE must be performed at 1, 4 and 8 hours post procedure to check if there are any pericardial effusions; *** 6 months X ray is optional

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Required Blood Test Measurements

NT Pro-BNP

CK-MB

Glucose

LDH

Blood Urea Nitrogen (BUN)

Total serum protein

INR

Serum albumin

SGOT/AST

Red Blood Cells

SGPT/ALT

Hemoglobin

Alkaline phosphatase

Hematocrit

Total bilirubin

White Blood Cells

Creatinine

Neutrophils

Creatinine Clearance

Lymphocytes

Creatinine Kinase (CK)

Platelet count

  • Normal lab values/lab certification will need to be collected
  • Values will need to be classified as normal/abnormal
    • If abnormal, clinical significance will need to be confirmed