Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System*

Completed

• Conditions: Percutaneous tricuspid valve repair; repair leaking heart valve.; 10046973

• Registration Number: NL-OMON43420
• Lead Sponsor: 4Tech Cardio Ltd.

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-04-25
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

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
contrast media that cannot be adequately premedicated.
7. 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)26.
8. Female patient is pregnant (urine HCG test result positive) or lactating.
9. Known alcohol or drug abuser.
10. Currently participating in the study of an investigational drug or device.
11. At heart team's judgement, patient IVC dimension is not adequate for device implantation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>-Acute safety at 30 days, defined as freedom from device related Major Adverse<br /><br>Events (MAE): death, Q-wave myocardial infarction, cardiac tamponade, cardiac<br /><br>surgery for failed TriCinch implantation, stroke, or septicaemia.<br /><br><br /><br>Performance:<br /><br>- Acute device delivery success.<br /><br><br /><br>- Ability to reduce tricuspid regurgitation by at least 1 degree immediately<br /><br>following implantation of the TriCinch device assessed by means of quantitative<br /><br>echo-cardiographic parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>- Rate of device related Major Adverse Events (MAE) at 3 and 6 months.<br /><br><br /><br>Performance:<br /><br>- Ability to maintain tricuspid regurgitation respect to baseline at 3 and 6<br /><br>months post-procedure.<br /><br>- Quality of life assessment at 6 months</p><br>