To evaluate the safety and performance of the TriCinch System* in the treatment of functional tricuspid regurgitation
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
-Acute safety at 30 days, defined as freedom from device related Major Adverse
Events (MAE): death, Q-wave myocardial infarction, cardiac tamponade, cardiac
surgery for failed TriCinch implantation, stroke, or septicaemia.
Performance:
- Acute device delivery success.
- Ability to reduce tricuspid regurgitation by at least 1 degree immediately
following implantation of the TriCinch device assessed by means of quantitative
echo-cardiographic parameters.
Secondary outcome
Safety:
- Rate of device related Major Adverse Events (MAE) at 3 and 6 months.
Performance:
- Ability to maintain tricuspid regurgitation respect to baseline at 3 and 6
months post-procedure.
- Quality of life assessment at 6 months
Background summary
The tricuspid valve may malfunction due to structural malformation secondary to
other cardiac pathology or due to hardware through the valve. The most common
presentation of TR is secondary to cardiac valvular pathology (mostly mitral
valve disease) on the left side of the heart. As pulmonary hypertension
develops, leading to right ventricular dilatation, the tricuspid valve annulus
will dilate. The circumference of the annulus lengthens primarily along the
attachments of the anterior and posterior leaflets. The septal leaflet is fixed
between the fibrous trigones, preventing lengthening. As the annular and
ventricular dilatation progresses, the chordal papillary muscle complex becomes
functionally shortened. This combination prevents leaflet apposition, resulting
in valvular incompetence.
The TriCinch System* percutaneous catheter-based device is designed for
tricuspid valve repair in order to decrease effective cross-sectional area and
relieve symptoms in patients with tricuspid valve regurgitation.
The 4TECH TriCinch System* implantation targets an unmet clinical need by
offering benefits that may include: treatment for high risk patient not
suitable for open-heart surgery, reduced pain, reduced risk of infection,
shorter hospital stay, faster recovery, less scarring, and to avoid the need
for reoperation or
replacement of the valve.
Study objective
To evaluate the safety and performance of the TriCinch System* in the treatment
of functional tricuspid regurgitation
Study design
Prospective, non-randomized, single-arm, multi-centres and open trial.
Intervention
The TriCinch System* is a percutaneous catheter-based device for tricuspid
valve repair. The TriCinch System* involves the placement of a novel tricuspid
implant in order to decrease effective cross-sectional area and relieve
symptoms in patients with tricuspid valve regurgitation. The female lock is
designed to couple with the male lock. Tension is applied to the embedded
implant to achieve coaptation of the leaflets of the Tricuspid valve and this
tension is maintained in the system through deployment of the stent.
Study burden and risks
Most of the test which are conducted during the study are standard of care. The
pregnancy test, blood tests at 30d, 90d en 6m, and the chest x-ray at 30 days
are study specific
Risk and burden:
Subject participation in this trial involves the standard risks for trans
catheter treatments of the heart. There are additional potential risk that are
cause by the use of the TriCinch device. All of these risks are analyzed and
controlled by 4TECH, in compliance with ISO 14971.
Next to the standard risk involved in the repair of the tricuspid heart valve,
risks specifically associated to the TriCinch System* include, but may not be
limited to the following:
- Failure of anchoring implant in the desired area of the tricuspid valve
(early or late)
- Failure of placing the stent in the vena cava (early or late)
- Unsuccessful tricuspid regurgitation reduction
- Tissue damage from insertion and removal of the delivery system
- Acute or chronic lesions
The 4TECH TriCinch System* is a medical device that will enable physicians to
perform tricuspid valve repair while the heart is beating as an alternative to
the open chest, arrested heart approach. The 4TECH TriCinch System* thus offers
an alternative treatment to the open heart surgery where the heart is stopped
which can offer significant potential benefits compared to existing treatments,
in particular for the treatment of high-risk patient..
The expected risks are comparable to the risks associated to those of
standard-transkatheter treatments of the heart and are compensated by the
potential benefits.
Unit 3, Ballybrit Business Park
Galway 6412CN
IE
Unit 3, Ballybrit Business Park
Galway 6412CN
IE
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02098200 |
| CCMO | NL56206.100.15 |