Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

Tricuspid Regurgitation Clinical Trial

— PREVENT  

Official title:

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098200
• Other study ID #: PREVENT_001/2013
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2014
• Last updated: March 13, 2018
• Start date: June 2013
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: 4Tech Cardio Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• TriCinch System
Percutaneous treatment of Tricuspid Regurgitation

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon
France	Bichat Hospital	Paris	Paris Cedex 18
France	Clinique Pasteur	Toulouse
Germany	Universitatsklinikum Bonn	Bonn
Germany	CardioVasculares Centrum Frankfurt	Frankfurt am Main
Germany	UKE Heart Center	Hamburg
Italy	Ferrarotto Hospital	Catania
Italy	Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci	Massa
Italy	Monzino Hospital	Milan	Lombardy
Italy	San Raffaele Hospital	Milano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	University Hospital Pisa	Pisa	Tuscany
Italy	Fondazione PTV Policlinico Tor Vergata	Roma
Netherlands	St. Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
4Tech Cardio Ltd.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life assessment	Compare to baseline at 6 months	6 months
Primary	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
Primary	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
Primary	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	Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.	Rate of device-related major adverse event (MAE).	3 months
Secondary	Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.	Rate of device-related Major Adverse Event (MAE).	6 months
Secondary	Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.	Ability to maintain Tricuspid Regurgitation with respect to baseline.	3 months
Secondary	Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.	Ability to maintain Tricuspid Regurgitation with respect to baseline.	6 months