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Completed

NCT Number: NCT02098200

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bichat Hospital, Paris, Paris Cedex 18, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TriCinch System

Device

Percutaneous treatment of Tricuspid Regurgitation

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Other outcomes

  1. Quality of Life assessment

    Time frame: 6 months

    Compare to baseline at 6 months

Sponsors and collaborators

Lead sponsor

4Tech Cardio Ltd.

Industry

Registry information

Acronym: PREVENT

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 27, 2014
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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