NCT03632967

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

August 9, 2018

Last Update Submit

July 30, 2020

Conditions

Functional Tricuspid RegurgitationHeart Valve DiseasesTricuspid Valve Insufficiency

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 in Effective Regurgitant Orifice Area (EROA) compared to Baseline

    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

  • +1 more secondary outcomes

Study Arms (1)

Device: TriCinch Coil System treatment

EXPERIMENTAL
Device: Tricinch Coil System Implantation

Interventions

Tricinch Coil System ImplantationDEVICE

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.

Device: TriCinch Coil System treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

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 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

HCA Research Institute at Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Piedmont Heart Hospital

Atlanta, Georgia, 30309, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Abbott Northwestern - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor Plano Heart Hospital

Plano, Texas, 75205, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Heart Valve DiseasesTricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular 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

August 9, 2018

First Posted

August 16, 2018

Study Start

September 12, 2018

Primary Completion

July 14, 2020

Study Completion

July 14, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(9)