Primary Safety Objective : To evaluate one month procedural and device safety of the Tendyne Bioprosthetic Mitral Valve System.Primary Safety Endpoint : Device success and freedom from the following device- or procedure-related serious adverse…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are no pre-defined pass or fail criteria for evaluating the study
objectives. Endpoints were selected to enable the sponsor, its safety
committees, and regulatory agencies the ability to compare estimates obtained
from this study to estimates from studies of other comparable procedures and
devices. Objectives and endpoints were selected based on input from medical
advisors experienced in related procedures and studies of other replacement
valves and devices used to treat mitral regurgitation.
Secondary outcome
* Length of ICU stay
* Length of hospital stay
* 30 day mortality
* 3-month mortality
Background summary
The purpose of this expanded clinical study is to evaluate the performance and
safety of the Tendyne Mitral Valve System in the treatment of severe mitral
regurgitation in patents with functional disability greater than or equal to
NYHA Class II, who are not suitable candidates for surgical replacement with
otherwise available devices. The data gathered in this study may be used to
support conformity requirements for CE Mark of the Tendyne system.
Study objective
Primary Safety Objective : To evaluate one month procedural and device safety
of the Tendyne Bioprosthetic Mitral Valve System.
Primary Safety Endpoint :
Device success and freedom from the following device- or procedure-related
serious adverse events (SAEs) at 30 days post implant, as classified by the
Clinical Events Committee (CEC):
* Cardiovascular death
* Reintervention caused by valve-related dysfunction
* Disabling stroke
* Myocardial infarction (MI)
* Life-threatening bleeding
* Renal failure requiring dialysis
* Other device-related SAEs
* Other procedure-related SAEs
Stroke and MI classifications will be per the Valve Academic Research
Consortium - 2 (VARC-2). Life-threatening bleeding classifications will be per
the Bleeding Academic Research Consortium (BARC) consensus (Type 2, 3, and 5).
Secondary Safety Objective :
To evaluate long-term safety of the Tendyne Bioprosthetic Mitral Valve System.
Secondary Saety Endpoint :
Through two years post implant:
* Device success and,
* No device or procedure related SAEs
Primary Performance Objective :
To evaluate the performance of the Tendyne Mitral Valve System
Study design
Nonclinical assessments, pre-clinical data, and acute clinical study data have
been used to evaluate the Tendyne Bioprosthetic Mitral Valve System design
concept. This study is required to collect further data.
This study is a single-arm, multicenter study. The subjects will be individuals
who have symptomatic mitral valve regurgitation and meet eligibility criteria.
Intervention
NA
Study burden and risks
Patients who are contraindicated for mitral valve replacement surgery - no
open-heart surgery - less invasive access leads to lower operative risk -
the use of cardiopulmonary bypass carries several risks will be avoided
County Road B 117 E
Minnesota 55117
US
County Road B 117 E
Minnesota 55117
US
Listed location countries
Age
Inclusion criteria
Subjects must meet ALL of the following criteria:
1. Severe mitral regurgitation of primary or secondary etiology.
2. New York Heart Association (NYHA) functional Class >= II. If Class IV,
patient must be ambulatory.
3. Heart team determines patient is not a suitable candidate for traditional
surgical treatment.
4. Age 18 years or older.
Exclusion criteria
Subjects will be excluded if any of the following criteria are met:
1. Severe mitral annular calcification, severe mitral stenosis, valvular
vegetation or mass.
2. Left Ventricle (LV) or Left Atrium (LA) thrombus.
4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
6. Prior surgical or interventional treatment of mitral or aortic valves
9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.
10. Symptomatic, unresolved multi-vessel or unprotected left main coronary
artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
14. Severe tricuspid regurgitation or severe right ventricular dysfunction.
15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or
any other structural heart disease causing heart failure other than dilated
cardiomyopathy of either ischemic or non-ischemic etiology.
17. History of endocarditis within six months of planned implant procedure.
21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
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 | NCT02321514 |
| CCMO | NL59117.100.16 |