Clinical trial NCT02098200: Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
Official title: Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tricuspid Regurgitation
Keywords: tricuspid
regurgitation
repair
outcomes
Lead sponsor: 4Tech Cardio Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
timeFrame: Up to 30 days
measure: Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
timeFrame: intraoperative
measure: Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
timeFrame: Time of discharge - 5 days
Secondary outcomes:
measure: Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
timeFrame: 3 months
measure: Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
timeFrame: 6 months
measure: Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
timeFrame: 3 months
measure: Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
timeFrame: 6 months
Other outcomes:
measure: Quality of Life assessment
timeFrame: 6 months
Locations:
city: Paris
country: France
facility: Bichat Hospital
state: Paris Cedex 18
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Frankfurt am Main
country: Germany
facility: CardioVasculares Centrum Frankfurt
city: Hamburg
country: Germany
facility: UKE Heart Center
city: Milan
country: Italy
facility: Monzino Hospital
state: Lombardy
city: Pisa
country: Italy
facility: University Hospital Pisa
state: Tuscany
city: Catania
country: Italy
facility: Ferrarotto Hospital
city: Massa
country: Italy
facility: Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
city: Milano
country: Italy
facility: San Raffaele Hospital
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: San Raffaele Hospital
name: Antonio Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References: