Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON43420
NL-OMON43420
Completed
N/A

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System* - *PREVENT* Study

4Tech Cardio Ltd.0 sites5 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPercutaneous tricuspid valve repairrepair leaking heart valve.10046973

Overview

Phase
N/A
Intervention
Not specified
Conditions
Percutaneous tricuspid valve repair
Sponsor
4Tech Cardio Ltd.
Enrollment
5
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
April 25, 2017
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
4Tech Cardio Ltd.

Eligibility Criteria

Inclusion Criteria

  • •1\. Functional symptomatic tricuspid regurgitation (TR) 2\+ to 4\+ on a scale of 4\+ (moderate to severe,
  • •according to semi\-quantitative echocardiographic color flow doppler evaluation)25 with symptoms such
  • •as fluid retention and severe oedema requiring use of diuretics, liver stasis, and severe dilatation of the
  • •tricuspid annulus (ie, annular diameter greater than 40 mm) confirmed by echocardiography
  • •2\. By subject signed and dated approved subject informed consent form prior to any study related procedure
  • •3\. Available and able to return to the study site for post\-procedural follow\-up examination.
  • •4\. Eighteen (18\) years of age or older.

Exclusion Criteria

  • •1\. 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.
  • •2\. 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.
  • •3\. Cerebro\-vascular event within the past 6 months.
  • •4\. History of mitral/tricuspid endocarditis within the last 12 months.
  • •5\. Organic tricuspid disease
  • •6\. Contraindication or known allergy to device\*s components, aspirin, anti\-coagulation therapy or

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 3
Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX)10011082Myocardial infarctionunstable angina with rest complaints
NL-OMON40840Società Italian di Cardiologia Invasiva GISE92
Completed
N/A
eft ventricular septum pacing in patients by transvenous approach through the inter-ventricular septum - feasibility, long-term lead stability and safetyHartaandoening: geleidingsstoornissenLeft ventricular dyssynchrony10019280
NL-OMON39464Medisch Universitair Ziekenhuis Maastricht12
Completed
N/A
Hemostasis in pediatric patients undergoing orthotopic liver transplantation: a prospective cohort study.
NL-OMON45316niversitair Medisch Centrum Groningen50
Completed
N/A
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance ImagingTricuspid Valve Insufficiency
NCT04522154Heart and Diabetes Center North-Rhine Westfalia30
Completed
N/A
Effect of Intravenous Administration of Recombinant Human Activated Protein C on Local Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Asthma PatientsAsthma10006436
NL-OMON35983Academisch Medisch Centrum28