Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

NCT03294200 | Terminated DMC

• 1 other identifier: CIP 2101-01
• Study Type: interventional
• Target: 18
• Locations: 7 countries
• Sites: 13

Brief Summary

The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality of the Per Protocol cohort at 30 days post procedure.

  30 days post procedure

Secondary Outcomes (6)

• 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 compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures

  30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure

• 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

• 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

Study Arms (1)

Tricinch Coil System treatment

EXPERIMENTAL

Device: TriCinch Coil System implantation

Interventions

TriCinch Coil System implantation DEVICE

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, without the need for surgical intervention.

Tricinch Coil System treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥ 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%.
• 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

You may not qualify if:

• 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, mitral and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
• Mitral valve 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

Sponsors & Collaborators

• 4Tech Cardio Ltd.: lead

Study Sites (13)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Monash Heart

Clayton, Victoria, 3168, Australia

Location

AZ Sint Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Rigshospitalet

Copenhagen, Denmark

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CardioVascular Center Frankfurt

Frankfurt am Main, 60389, Germany

Location

St Antonius Hospital

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Brighton & Sussex University Hospitals - Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX9 3DU, United Kingdom

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: August 28, 2017
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

GB (4); DE (1); DK (1); AU (3); FR (1); NL (2); BE (1)