The primary objective is to evaluate the safety and effectiveness of the PULSTA TPV System for the treatment of congenital or acquired heart disease with pulmonary valve disease and to gain data that will lead to CE mark approval for the PULSTA TPV…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Procedural / Device related-serious adverse events at 6 months
2. Hemodynamic functional improvement at 6 months
* Hemodynamic functional improvement is defined as mean RVOT gradient <=30 mmHg
by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac
MRI
Secondary outcome
Secondary Effectiveness endpoints are:
* Procedural success at discharge (Visit 3)
* Procedural success is defined as follows:
o If TPV is implanted on the desired site
o RV-PA peak systolic pressure gradient <35mmHg on cardiac catheterization
o If pulmonary regurgitation is < mild as assessed by angiography or
echocardiography
o If TPV is not removed within 24 hours following implantation
* Hemodynamic function at all follow-up visits (Visits 3-10)
o Peak RVOT pressure gradient (by TTE)
o Mean RVOT pressure gradient (by TTE)
o RV end-diastolic volume index (RVEDV, by cardiac MRI at Visit 5)
* Pulmonary Regurgitant Fraction (PRF, by cardiac MRI at Visit 5)
* Severity of pulmonary regurgitation (Doppler echocardiography, Visit 1 and
Visit 3-10)
* NYHA functional classification (classification scale, Visit 1 and Visit 3-10)
Background summary
(Protocol section 1.)
Various congenital heart diseases, such as tetralogy of Fallot (TOF) involve a
right ventricular outflow tract (RVOT) lesion, the treatment of which may lead
to significant stenosis of the right ventricular outflow tract (=RVOT) or
pulmonary regurgitation (insufficiency).
The treatment is either performed surgically replacing the pulmonary valve or
transcutaneous using heart catherization. For artificial valves patients
normally require anti-coagulation medication for life. For bioprosthetic valves
no anti-coagulation medication is provided, however max. thrombocyte
aggregation inhibition is required (e.g. Aspirin). These valves can degenerate
over time resulting in multiple interventions.
Percutaneous implantation of pulmonary valves with the use of balloons (PPVI)
does have restrictions, as the valve does not shape like the RVOT, but its
shape is defined by the balloon. Especially in calcified RVOT this can create a
risk of tearing. Also, the coronary arties running next to the RVOT may be
compromised by the valve implantation.
The PULSTA Transcatheter Pulmonary Valve (TPV) System has been developed by
Taewoong Medical Co., Ltd. and is a self-expandable valve with flared-ends to
adapt to the larger native RVOT from knitted nitinol wire backbone(stent) and
trileaflets made from treated porcine pericardial tissue. The device is using a
relatively low profile delivery catheter.
Initial clinical results with the PULSTA TPV in patients with TOF demonstrated
good short-term effectiveness without serious device related events (Kim et
al., 2018). The current clinical investigation has been designed to meet the
essential requirements of safety and performance for the PULSTA TPV System as
intended for its CE marking in Europe.
Study objective
The primary objective is to evaluate the safety and effectiveness of the PULSTA
TPV System for the treatment of congenital or acquired heart disease with
pulmonary valve disease and to gain data that will lead to CE mark approval for
the PULSTA TPV System.
The secondary objectives are to evaluate the procedural success and hemodynamic
function and safety of the PULSTA TPV System.
Study design
To support the CE marking of the PULSTA TPV System, the Sponsor will conduct a
prospective, multinational, multicenter, non-randomization, open-label study to
evaluate the safety and effectiveness of the PULSTA TPV implantation for the
treatment of congenital or acquired heart disease with pulmonary valve disease.
All subjects included in the study and that fulfill the inclusion and exclusion
criteria will receive the PULSTA TPV. No comparator valves or other treatments
will be used in this clinical investigation. The device will not be explanted,
other than if indicated or based on the investigator*s judgment. Subjects will
be followed for 5 years.
Intervention
The PULSTAT(TM) Transcatheter Pulmonary Valve (TPV) System.
The PULSTA TPV is a self-expandable valve with flared-ends from knitted nitinol
wire backbone to adapt to the larger native right ventricular outflow tract
(RVOT) and valve leaflets made from treated porcine pericardial tissue, and a
low-profile delivery system, which provides access to the right ventricular
outflow tract through blood vessels.
Study burden and risks
Not applicable.
Gojeong-ro, Wolgot-myeon 14
Gimpo-si 10022
KR
Gojeong-ro, Wolgot-myeon 14
Gimpo-si 10022
KR
Listed location countries
Age
Inclusion criteria
1. Males and females aged >=16 years and weight >=30kg
2. Patients who are diagnosed with congenital or acquired heart disease with
pulmonary valve disease and meet one or more of the following criteria:
- Moderate or severe pulmonary valve regurgitation as assessed by
echocardiography
- Pulmonary valve stenosis with a mean gradient >35mmHg as assessed by
echocardiography
3. Patients who have main pulmonary artery trunk of >=16 mm and <=30 mm
4. Patients whom are willing to participate in the study and willing to comply
with the required treatments, procedures and attend all follow-up evaluations.
5. Patients who have been informed of the nature of the study, and have
voluntarily provided written informed consent
Exclusion criteria
1. Females of child-bearing potential who are unable to take adequate
contraceptive precautions, are known to be pregnant, or are currently
breastfeeding an infant up until 6 months after TPV implantation
2. When patients have a mechanical valve implanted previously in pulmonary
position or who require concomitant repair of other cardiac valves
3. When it is impossible to insert the delivery system since the central veins
to be approached for the TPV implantation are obstructed
4. Patients who have coronary artery compression confirmed by angiography
5. Patients have known severe allergy to Nickel
6. Patients have a known hypersensitivity to any anticoagulation therapy, or a
hemorrhagic disease
7. Patients have an immunocompromising disease such as malignant tumor or bone
marrow transplant, or are immunosuppressed by chemotherapy, immunosuppressant,
etc.
8. Patients have a known or suspected active infectious disease requiring
antibiotic treatment such as meningitis, endocarditis, etc.
9. Patients have a known hypersensitivity to contrast agent or have severe
renal insufficiency.
10.Patients with absolute or relative contraindications for MRI
11. Patients have less than 6 months of life expectancy according to the
investigator*s clinical judgment
12. When patients have participated in a clinical study with other
investigational drug or device within the past 3 months
13. When TPV implantation is impossible by the investigator*s judgment
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 | NCT03983512 |
| CCMO | NL68549.078.19 |