Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Detailed Description

Implantation Procedure: Unlike the standard open chest, arrested heart approach, the 4TECH TriCinch System™ provides a percutaneous solution for tricuspid valve regurgitation treatment: this procedure is performed through deep sedation, while the heart is beating, without the need for respiratory assistance.

The TriCinch System™ consists of a Delivery System that enables transcatheter placement of an implant that can be adjusted to correct Tricuspid valve regurgitation. The TriCinch Delivery System is inserted from the femoral vein to access the right atrium of the heart. At the end of the correction process, the TriCinch Delivery System and the venous introducer are removed and the procedure is concluded.

Interventions

  • Device: TriCinch System
    • Percutaneous treatment of Tricuspid Regurgitation

Arms, Groups and Cohorts

  • Experimental: Percutaneous treatment of TR by TriCinch
    • Percutaneous treatment of Tricuspid Regurgitation with TriCinch System

Clinical Trial Outcome Measures

Primary Measures

  • Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
    • Time Frame: Up to 30 days
    • Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
  • Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
    • Time Frame: intraoperative
    • Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
  • Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
    • Time Frame: Time of discharge – 5 days
    • Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.

Secondary Measures

  • Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
    • Time Frame: 3 months
    • Rate of device-related major adverse event (MAE).
  • Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
    • Time Frame: 6 months
    • Rate of device-related Major Adverse Event (MAE).
  • Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
    • Time Frame: 3 months
    • Ability to maintain Tricuspid Regurgitation with respect to baseline.
  • Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
    • Time Frame: 6 months
    • Ability to maintain Tricuspid Regurgitation with respect to baseline.

Participating in This Clinical Trial

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • 4Tech Cardio Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio Colombo, MD, Principal Investigator, San Raffaele Hospital

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