The primary objective of this trial is to test the safety and efficacy of Perceval valve versus standard sutured stented bioprosthetic aortic valves among the intended trial population. The secondary objective is to compare all relevant device and…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is freedom from MACCE (composite endpoint of all cause
death, myocardial infarction, stroke, and valve re-intervention) at one year
based on CEC adjudication
Secondary outcome
1. Surgical time
a. Cross clamp time during index procedure
b. Cardiopulmonary bypass time during index procedure
2. Normalized Consumption Index and reduced Normalized Consumption Index,
including resource consumption items such as (but not limited to):
a. Operative room time,
b. Duration of ICU/CCU and total hospital stay
c. Incidence of specific serious adverse events as defined in Appendix 3
d. Blood transfusion(s)
3. Quality of life questionnaire
b. At 1 month and 1 year post surgery
4. Intraprocedural and periprocedural serious adverse events regardless of
relationship with the device within 72 hours
5. All valve and procedure relevant serious adverse as specified in VARC-2
guidelines
a. Early safety at 30 days
b. Clinical efficacy after 30 days
c. Time related valve safety: SVD, endocarditis, thrombosis, thromboembolic
events (excluding stroke), and bleeding annually up to 5 years
6. Serious device related adverse events up to 5 years
7. Freedom from MACCE at 2, 3, 4 and 5 years of follow up
8. Pacemaker implantation and cause up to 1 year
9. Valve hemodynamics (PPM, PPG, MPG; DVI, EOA, LVOT, AI, PVL, EROA) assessed
by site-reported echocardiographic parameters preoperatively, at discharge,
between 1-3 month, 1 year, 3 year and 5 year.
10. Valve hemodynamics (PPM, PPG, MPG; DVI, EOA, LVOT, AI, PVL, EROA) in a
reduced cohort of patients assessed by core lab echocardiographic parameters
preoperatively, at discharge, between 1-3 month, 1 year, 3 year and 5 year.
Background summary
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis
manufactured with bovine pericardium and assembled on a Nitinol stent. The
Perceval valve is designed to offer an alternative to stented and stentless
biological valves. A special feature of the device is that it is
self-anchoring and does not require sutures to be fixed to the implant site.
Due to the lack of prospective, randomized comparison data between sutureless
valve and standard aortic valve, this randomized study is planned to
demonstrate, as primary endpoint, the non inferiority of Major Adverse Cardiac
and Cerebrovascular (MACCE) events at one year
Study objective
The primary objective of this trial is to test the safety and efficacy of
Perceval valve versus standard sutured stented bioprosthetic aortic valves
among the intended trial population.
The secondary objective is to compare all relevant device and subject
demographics, procedural and hospital discharge, short and long-term data, as
described in the secondary endpoints section
Study design
This is a prospective, randomized (1:1), stratified non blinded multi-center,
international study
A maximum of 1234 patients are planned to be enrolled, but accrual may stop
earlier at approximately 900 or 1050 subjects.
Patients will be evaluated at different time intervals:
- pre-operatively (including CT scan)
- At implant (including transesophageal echocardiography- TEE)
- 1 month after implant (hospital discharge or within 30 days postoperatively)
- Between 1 to 3 months postoperatively
- At 1 year (postoperatively between 11 and 13 months) and
- Annually until study completion (2 and 4 year visit can be done via phone)
A transthoracic echocardiographic (TTE) assessment, physical examination
(including NYHA assessment and ECG) and blood tests will be performed at every
clinical visit.
Intervention
Besides the heartvalve replacement procedure/operation (standard
treatment/practice), a transthoracic echocardiographic (TTE) assessment,
physical exam (including NYHA and ECG) and blood tests will be performed at
every visit. A transesophageal echocardiography (TEE) assessment will be
performed at implant.
Study burden and risks
The most obvious benefit from implant of a bioprosthetic valve is overall
improvement in patient condition as a result of improved heart valve function.
The risks and discomforts associated with the use of the Perceval valve are not
expected to exceed the frequency and severity of those reported with other
aortic bioprosthethic valves.
Minimization of the risks will be accomplished by selection of patients who are
appropriate candidates for implant with a bioprosthesis.
Via Crescentino -
Saluggia 13040
IT
Via Crescentino -
Saluggia 13040
IT
Listed location countries
Age
Inclusion criteria
1. The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy.
2. The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan.
3. The subject has:
a. critical aortic valve area defined as an initial aortic valve area of *1.0 cm2 or aortic valve area index < 0.6 cm2/m2
AND
b. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization [or with dobutamine stress, if subject has a left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
4. The subject is symptomatic due to aortic stenosis with functional class of NYHA II or higher.
5. The subject has signed the informed consent.
6. The subject is of legal minimum age.
7. The subject will be available for postoperative follow-up beyond one year.
Exclusion criteria
1. The subject has a contraindication for treatment by the Perceval valve or by a bioprosthetic aortic valve as stated in the IFU.
2. The subject has aneurismal dilation or dissection of the ascending aortic wall.
3. The subject is scheduled for concomitant procedures other than CABG, myectomy with or without aortic annulus enlargement.
4. The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve.
5. Anatomical structures not suitable for Perceval valve such as: aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is > 1.3.
6. The subject has a prosthetic heart valve in any position, including mitral valve repair.
7. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days prior to the planned valve implant surgery.
8. The subject has active endocarditis, myocarditis, or sepsis.
9. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support.
10. The subject is allergic to nickel alloys.
11. The subject is already included in another clinical trial that could confound the results of this clinical investigation.
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 | NCT02673697 |
| CCMO | NL56524.068.16 |