Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

NCT02098200 | Completed Phase 1 DMC

• 1 other identifier: PREVENT_001/2013
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 14

Brief Summary

The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.

Conditions

Tricuspid Regurgitation

Keywords

tricuspid; regurgitation; repair; outcomes

Outcome Measures

Primary Outcomes (3)

• Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.

  Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.

  Up to 30 days

• Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.

  Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.

  intraoperative

• Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.

  Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.

  Time of discharge - 5 days

Secondary Outcomes (4)

• Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.

  3 months

• Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.

  6 months

• Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.

  3 months

• Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.

  6 months

Other Outcomes (1)

• Quality of Life assessment

  6 months

Study Arms (1)

Percutaneous treatment of TR by TriCinch

EXPERIMENTAL

Percutaneous treatment of Tricuspid Regurgitation with TriCinch System

Device: TriCinch System

Interventions

TriCinch System DEVICE

Percutaneous treatment of Tricuspid Regurgitation

Percutaneous treatment of TR by TriCinch

Eligibility Criteria

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

You may qualify if:

• Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe), with annular dilatation greater than 40mm.
• Signed informed consent form prior to any study-related procedure.
• Available and able to return to the study site for post-procedural follow-up examination
• Eighteen (18) years of age or older.

You may not qualify if:

• Requirement for concomitant cardiac procedure (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or PTCA (percutaneous treatment of coronary artery) or CAD (coronary artery bypass surgery) from 1 to 3 months after or before other procedure.
• Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year.
• Cerebro-vascular event within the past 6 months.
• History of mitral/tricuspid endocarditis within the last 12 months.
• Organic tricuspid disease.
• Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated.
• Severe hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg, measurement done by sphygmomanometer with stethoscope, allow the patient to sit for at least 5 minutes before beginning BP measurements).
• Female patient is pregnant (urine HCG test result positive) or lactating.
• Known alcohol or drug abuser.
• Currently participating in the study of an investigational drug or device.
• At heart team's judgement, patient IVC dimension is not adequate for device implantation.

Sponsors & Collaborators

• 4Tech Cardio Ltd.: lead

Study Sites (14)

Bichat Hospital

Paris, Paris Cedex 18, 75877, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

CardioVasculares Centrum Frankfurt

Frankfurt am Main, 60389, Germany

Location

UKE Heart Center

Hamburg, Germany

Location

Monzino Hospital

Milan, Lombardy, 20121, Italy

Location

University Hospital Pisa

Pisa, Tuscany, 56124, Italy

Location

Ferrarotto Hospital

Catania, 95124, Italy

Location

Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci

Massa, 54100, Italy

Location

San Raffaele Hospital

Milan, 20129, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, 3430EM, Netherlands

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Antonio Colombo, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 27, 2014
• Study Start: June 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

DE (3); FR (3); NL (1); IT (7)