Primary objective: To generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. Secondary objective: To evaluate the…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All-cause mortality of the primary endpoint cohort at 30 days post procedure.
Secondary outcome
• Technical success defined as (per MVARC) at post-procedure and 30 days
post-procedure: absence of procedural mortality; and successful access,
delivery, and retrieval of the device delivery system; and successful
deployment and correct positioning of the first intended device; and freedom
from emergency surgery or reintervention related to the device or access
procedure.
• Number of individual adverse events related to the system or procedure at 30
days, three (3), six (6), twelve (12) and twenty-four (24) months, also
expressed as a percentage.
• Echocardiographic improvement at 30 days, three (3), six (6), twelve (12) and
twenty-four (24) months compared to Baseline by means of echocardiographic
semi-quantitative and quantitative measures (e.g. TV annular diameter, TV area,
vena contracta, PISA EROA, Quantitative EROA, TV Regurgitant Volume, RA, RV,
IVC dimensions, TAPSE). The independent Echo core lab measurements will be used
to evaluate this secondary endpoint.
• Functional improvements at 30 days, three (3), six (6), twelve (12) and
twenty-four (24) months as compared to Baseline for New York Heart Association
(NYHA) classification, Exercise tolerance (Six Minute Walk Test) and Quality of
Life evaluation (Kansas City Cardiomyopathy Questionnaire).
• Rate of Heart Failure event post-procedure defined as a heart failure
hospitalization or a heart failure hospitalization equivalent at three (3), six
(6), twelve (12) and twenty-four (24) months (further details in Section 6.2.5.)
• Changes in peripheral oedema at 30 days, three (3), six (6), twelve (12) and
twenty-four (24) months
• New onset of Atrial Fibrillation at 30 days, three (3), six (6), twelve (12)
and twenty-four (24) months
• Change in average dosages of concomitant cardiac medications (including
diuretics) at 30 days, three (3), six (6), twelve (12) and twenty-four (24)
months
• Kidney function at 30 days, three (3), six (6), twelve (12) and twenty-four
(24) months as compared to Baseline
• Change in NT-ProBNP at 30 days, three (3), six (6), twelve (12) and
twenty-four (24) months as compared to Baseline
• Procedure time
• Radiation dose during the procedure
Background summary
The goal of this clinical study is to evaluate the safety and performance of
the TriCinchTM Coil System as a new method to treat leaking tricuspid valves
which cause regurgitation (backflow of blood).
A leaking Tricuspid valve may be caused by various reasons. Often, the cause
can be a different valve disease of the left side of the heart but also it can
be unknown what the cause is.
When high blood pressure (hypertension) develops in the arteries of the lungs
it can lead to dilation of the right heart chamber and the tricuspid valve
annulus becomes enlarged (dilates). This can result in incorrect positioning of
the tricuspid valve leaflets which prevents the valve from functioning properly.
Today, "open heart" surgery is the standard treatment for this disease. The
risks associated with this surgical procedure are high for certain patients.
Unlike standard surgical treatment, the TriCinch* Coil System offers a
percutaneous treatment (access through the vein at the groin) to treat the
leaking tricuspid valve, without the need for surgical intervention.
Study objective
Primary objective:
To generate safety and performance data for the 4Tech TriCinch Coil System in
symptomatic patients suffering from moderate to severe functional tricuspid
regurgitation with annular dilatation.
Secondary objective:
To evaluate the long-term safety of the device and the effects of the device on
echocardiographic, functional and quality of life parameters.
Study design
Multi-center, prospective, single-arm, non-randomized study
Intervention
On the day of the TriCinch* Coil System procedure, the physical condition of
the patient will be evaluated, and an electrocardiogram (ECG) will be taken.
The procedure may be done under a general anaesthetic or with a local
anaesthetic and sedation. The type of anaesthetic used for procedure and the
reason why will be discussed between the patient and the doctor. During the
procedure, the tricuspid valve leakage will be assessed using TOE
(transoesophageal echocardiography - an ultra sound using a probe which is
placed in your oesophagus) &/or intracoronary echocardiogram (ICE an ultrasound
placed inside the heart) and angiography (dye injections) to enable the doctors
to view images of the heart & the device. Local anaesthetic will be injected
into the groin to numb the area. First, a small volume of gas (carbon dioxide)
is injected so the area surrounding the heart can be appropriately visualized.
Then, the system is inserted through a vein in the groin (femoral vein) and is
then passed through the inferior vena cava (large vein) which leads to the
right side of the heart. The tricuspid valve is then accessed and the
TriCinch* Coil System will be implanted. During the procedure, a pericardial
drain (needle inserted through the chest wall) is placed in order to remove any
abnormal fluid accumulation around the heart. This drain will stay in place for
24h if no fluid accumulates around your heart; or longer until all fluid
accumulated around your heart has been removed.
Study burden and risks
Participation in this clinical trial may involve certain risks associated with
medications / treatments and/or linked to the medical exams:
• Allergic reaction
• Anaphylactic shock
• Aortic dissection
• Aortic insufficiency
• Arterial dissection
• Cardiac arrhythmia, including atrial fibrillation and compromised AV node
• Cardiac tamponade/pericardial effusion
• Coronary artery obstruction
• Coronary artery puncture
• Delay in treatment
• Dissection, any vessel
• Dyspnea
• Esophagus irritation/perforation
• Gastro-intestinal bleeding
• Heart failure exacerbation
• Hematoma, haemorrhage or bleeding
• Hemodynamic deterioration
• Hemolysis
• Infection
• Inferior vena cava puncture
• Inflammation
• Myocardial infarction
• Myocardial ischemia, mild, moderate or severe
• Peripheral ischemia
• Pneumothorax
• Prolonged ventilation
• Prolonged exposure to fluoroscopic radiation
• Pseudo-aneurysm
• Pulmonary edema
• Pulmonary embolism
• Renal failure
• Renal insufficiency
• Right ventricular failure
• Septicemia
• Stroke or transient ischemic attack
• Tissue erosion
• Venous dissection
• Venous occlusion
• Venous perforation
• Venous thrombosis
• Ventricular arrhythmia, including ventricular tachycardia and fibrillation
• Vessel spasm
The potential risks specifically associated with the tricuspid valve procedures
include, but may not be limited to, the following:
• Reoperation and explants;
• Residual or recurrent regurgitation requiring intervention; failure to reduce
tricuspid regurgitation in the long term;
• Stenosis; hemolysis; atrioventricular block;
• Endocarditis; low cardiac output; right heart failure;
• Failure or degeneration of the natural valvular apparatus due to progression
of disease;
• Inadequate repair of the valvular and sub-valvular structure
• Partial detachment/dislodgment (partial or full) of the coil or stent
component from its site of attachment; migration or malposition;
• Malfunction of the coil or stent component due to distortion or fracture at
the implant or physical or chemical deterioration of tensioning band components;
• Bleeding complications related to use of anticoagulant therapy;
• Device thrombosis; infection.
The risks associated specifically to the TriCinch Coil include, but may not be
limited to the following:
• Failure of anchoring implant in the desired area of the pericardial space;
• Failure of placing the stent in the vena cava;
• Vessel perforation or tissue damage or vascular injury due to coil insertion
or stent deployment;
• Unsuccessful adjustment during system tensioning;
• Unsuccessful tricuspid regurgitation reduction;
• Tissue damage from insertion and removal of the delivery system;
• Acute or chronic lesions.
• Needle insertion damage to heart wall from inadvertent exposure of needle.
• Pericardial effusion/tamponade from insufficient haemostasis around coil
implant.
The risks associated with the pericardial drain (needle inserted through the
chest wall) not covered above include, but may not be limited to the following:
• Right Ventricle to Abdomen fistula (abnormal connection between the abdomen
and the lower right heart chamber)
• Haemoperitoneum (presence of blood in the peritoneal cavity)
The staff of the hospital's Cardiology Department will treat the patient with
the appropriate care and skill to prevent the risks described above from
occurring and, if they do occur, to resolve them adequately. Serious
complications requiring emergency heart surgery will be addressed immediately.
A heart surgery team is present and operational at the site 24 hours a day.
As with any device undergoing clinical investigation, there may be
unforeseeable risks, which are not known at this time. Medical and/or surgical
intervention may be required to correct clinical complications associated with
the device procedure.
Radiation Exposure
Taking part in this trial will involve exposure to ionizing radiation, through
fluoroscopic imaging to assist in the procedure to insert the 4 Tech TricinchTM
Coil System device, as well as through a CT scan of the heart and through chest
x-rays one month and 6 months following the procedure. The device implantation
procedure and the cardiac CT scan procedure will be part of normal care whether
or not the patient is participating in this trial, and only the radiation from
the chest x-rays may be additional to the normal care.
The dose of radiation from all of these procedures could be up to 35 mSv. This
dose of radiation is equivalent to approximately 17.5 years of natural
background radiation to which we are all subjected.
POTENTIAL BENEFITS ASSOCIATED WITH PARTICIPATING IN THIS STUDY
The TriCinch* Coil System is a medical device that enables physicians to treat
tricuspid valve leakage while the heart is beating, as opposed to an "open
heart" approach, where the heart is stopped. Because this device is less
invasive and avoids most of the complications associated with "open heart"
surgery, it targets an unmet medical need and the benefits may include:
• a treatment for high-risk patients in whom open-heart surgery is
contraindicated
• avoiding chest incisions;
• reduced pain;
• avoiding extracorporeal circulation and heart stoppage for the majority of
patients;
• the ability to evaluate the results of treating tricuspid leakage while the
heart is completely
functional at the end of the procedure, so that correction of the tricuspid
leakage can be
optimized;
• shorter hospitalization and faster recuperation.
It is not possible to know in advance whether participating in the trial will
benefit the patient or not, even if it is believed that there will very likely
be an improvement in your symptoms. In any case, the data collected will be
used to improve the features of the device and implantation procedure, which
will help optimize the therapy for future patients suffering from this
condition. The device was tested during preclinical studies and deemed
appropriate for implantation in humans.
Ballybrit Business Park 3
Galway H91DT7C
IE
Ballybrit Business Park 3
Galway H91DT7C
IE
Listed location countries
Age
Inclusion criteria
1. Moderate to severe functional tricuspid regurgitation (TR) defined as:
• TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color
flow doppler evaluation), and
• Annular diameter >= 40 mm confirmed by echocardiography
2. >= 18 years old
3. Subject has read and signed the informed consent prior to study related
procedures.
4. Willing and able to comply with all required follow-up evaluations and
assessments.
5. The 'Heart Team' assessment recommends TriCinch Coil Implantation. NOTE: At
this time, the Heart team will not recommend TriCinch Coil Implantation on
patients with a history of cardiac surgery. For more information, refer to
Section 8.1.1.
NOTE 2: The Heart team will recommend TriCinch Coil implantation for patients
classified as high-risk for open heart surgery. For more information, refer to
Section 8.1.
6. New York Heart Associate Classification >= II.
7. Left Ventricular Ejection Fraction >= 30%.
8. Heart failure symptoms (such as fluid retention and severe oedema, liver
stasis) despite on optimized medical therapy by the local heart team; at
minimum subject on diuretic use
9. Subject has suitable anatomy for investigational device implantation as per
imaging requirements
Exclusion criteria
1. Currently participating in another investigational drug or device study.
2. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as
measured by Transthoracic Echocardiography (TTE)
NOTE: In case the sPAP measured by TTE is 60 mmHg or more, a right heart
catheter should be performed during screening to confirm whether or not the
patient can be enrolled into the study
3. Subject requiring another cardiac procedure in the framework of the index
procedure; subject requiring a percutaneous procedure within 30 days before or
after the procedure or a cardiac surgical procedure within 3 months before or
after the procedure
4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient >=5
mmHg at normal heart rate)
5. Aortic and/or pulmonic valve stenosis and/or regurgitation more than or
equal to moderate
6. Mitral valve stenosis and/or regurgitation more than moderate
7. Intra-cardiac thrombus, mass or vegetation requiring active treatment
8. Implanted inferior vena cava (IVC) filter.
9. Prior tricuspid repair or tricuspid replacement
10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or
nitinol that cannot be adequately pre-medicated
11. History of cardiac transplantation
12. Contraindication to Transthoracic/Transoesophageal Echocardiography
(TTE/TOE).
13. Endocarditis or severe infection within 12 months of scheduled implant
procedure
14. Myocardial Infarction (MI) or known unstable angina within the 30 days
prior to the index procedure
15. Cerebro Vascular Accident within the previous 6 months
16. Hemodynamic instability or on IV inotropes
17. Contraindication to anticoagulant therapy and dual antiplatelet therapy
18. Bleeding disorders or hypercoagulable condition (at risk of blood clots)
19. Active peptic ulcer or active GI bleeding within 3 months of scheduled
implant procedure
20. Severe renal impairment or on dialysis
21. Life expectancy less than 12 months.
22. Acute anemia
23. Chronic Oral Steroid Use >= 6 months
24. Pregnant or lactating female of childbearing potential with a positive
pregnancy test 24 hours before any study-related radiation exposure
25. Pulmonary embolism within the last 6 months
26. Tricuspid Valve Tethering distance > 10 mm
27. Presence of trans-tricuspid pacemaker or defibrillator leads which are
determined as immobile or interfering with the procedure, as evaluated by
echocardiography.
28. Contra-indicated for blood transfusion or refuses transfusion
29. Patient undergoing emergency treatment
30. Patient without appropriate venous access
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 | NCT03294200 |
| CCMO | NL62459.100.17 |