The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of subjects with Device- and/or Procedure-related Major Adverse
Events (MAEs) within 30 days of the procedure, as classified by the Clinical
Events Committee (CEC).
MAEs consists of the following:
• Death (all cause, including cardiovascular and non-cardiovascular mortality)
• Myocardial Infarction (MI)
• Disabling Stroke
• Life-threatening bleeding (TVARC Bleeding Type 5 definition)
• Pulmonary embolism
• Renal failure requiring dialysis
• Need for additional surgical or interventional procedures
(reintervention/re-operation) due to device deficiency
• Major access site and vascular complications
Stroke and bleeding classifications will be per TVARC. MI classifications will
be per Valve Academic Research Consortium 3 (VARC-3).
The primary safety endpoint components will be analyzed and reported
individually. The primary safety endpoint does not represent a composite
endpoint.
Clinical Efficacy (measured at 30 days):
o Reduction in tricuspid valve regurgitation compared to baseline as
measured by the Imaging Core Labs
o Changes in symptom status (NYHA class)
o Changes in functional capacity (6-minute walk test) and
o Improvement in quality of life (KCCQ)
Secondary outcome
Safety: The percentage of subjects with Device- and/or Procedure related MAEs within 1 year post-procedure, as classified by the CEC. Mortality: The following mortality endpoints will be reported within 30 days postimplant: o All-cause mortality; o Cardiovascular mortality; o Non-cardiovascular mortality; o Procedural mortality (30 days from procedure or discharge from the hospital, whichever is longer); o Device related mortality Clinical Efficacy (measured at 3 months, 6 months and 1 year): o Reduction in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs o Changes in symptom status (NYHA class) o Changes in functional capacity (6-minute walk test) and o Improvement in quality of life (KCCQ) Intra-Procedural Success Intra-procedural success is defined below and will be evaluated upon exit from the procedure room: 1. Absence of procedural mortality or stroke; and 2. Successful access, delivery, and retrieval of the device delivery system; and 3. Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and 4. Adequate performance of the transcatheter device. This includes the absence of tricuspid stenosis (TVA >1.5 cm2 or TVAi >0.9 cm2/m2 [>0.75 if BMI >30 kg/m2], DVI <2.2, mean gradient <5 mm Hg); reduction of total tricuspid regurgitation to optimal (1.5 cm2 or TVAi >0.9 cm2/m2 [>0.75 if BMI >30 kg/m2], DVI <2.2, mean gradient <5 mm Hg); reduction of total tricuspid regurgitation to optimal (1 functional class); and/or Improvement from baseline in functional status (e.g., 6-min walk test improvement by >50 m); and/or Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by >5).
Background summary
Tricuspid valve regurgitation (TR) is estimated to impact 1.6 million people in
the United States. Despite its high prevalence, TR is a largely untreated
condition. and is known to be associated with poor life expectancy. Left
uncorrected, moderate or greater secondary TR may progress is associated with
higher heart failure hospitalization rates, increased morbidity and mortality,
and poor quality of life.
Study objective
The purpose of this clinical study is to collect safety and efficacy data of
the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne
System.
Study design
This study is a prospective, single-arm, multicenter, confirmatory, pre-market
investigational study, to support conformity assessment and CE Mark of the
VDyne System.
Intervention
The VDyne Valve is deployed by transfemoral implantation within the native
tricuspid valve and is implanted under fluoroscopic and transesophageal
echocardiography (TEE) guidance, while the heart remains beating, without the
use of CPB. The valve is repositionable and fully retrievable intraoperatively.
Study burden and risks
The innovative VDyne System and side delivery approach represents a
breakthrough technology where limited treatments currently exist for TTVR.
Alternative therapies for TR currently include:
• Pharmaceutical treatment
• Open surgical valve repair techniques such as annuloplasty rings
• Open surgical valve replacement (mechanical or bioprosthetic valve)
• Transcatheter tricuspid valve repair (TTV Repair) techniques
• Transcatheter tricuspid valve replacement (TTVR)
The potential expected benefits of the VDyne System and procedure over
available alternative therapies include:
• A safer procedure (e.g., potentially less time under general anesthesia, less
blood loss, less morbidity, etc.) than open surgical valve repair or
replacement due to the less invasive approach used to place the VDyne Valve.
The VDyne procedure can be completed without the need for CPB,
eliminating the risks and adverse consequences associated with open
heartsurgery.
This may further decrease the risk of the procedure in patients who have
advanced disease and thereby increased procedural risk.
• Preservation of the patient*s native tricuspid annulus, limiting interaction
with surrounding anatomical features.
• The ability to reposition the VDyne Valve intraoperatively may also result in
better performance as the VDyne Valve position within the native tricuspid
annulus can be optimized intraoperatively.
• The ability to fully retrieve the VDyne Valve intraoperatively allows use of
an alternative valve size or removal of the index VDyne Valve in the event of
suboptimal valve delivery or other intraoperative complication.
The benefits that the VDyne System can give to patients suffering from TR are
important, considering that the VDyne System can give opportunities for therapy
to patients that are excluded for other surgical options. The overall risks
associated with the use of the VDyne System are expected to be similar to risks
associated with percutaneous transcatheter valve replacement and less than
those compared to surgical valve repair or replacement due to the minimally
invasive nature of the procedure. It is concluded that the likely benefits to
patients, physicians, medical
science and society of the VDyne Transcatheter Tricuspid Valve Replacement
System outweigh the potential risks.
73rd Ave N Suite 116
Maple Grove 10900
US
73rd Ave N Suite 116
Maple Grove 10900
US
Listed location countries
Age
Inclusion criteria
1. Severe or greater tricuspid valve regurgitation of primary or secondary
etiology.
2. NYHA class >= II. If NYHA Class IV, patient must be ambulatory.
3. Subject is adequately treated with medical therapy for heart failure > 30
days prior to index procedure, including a diuretic.
4. Heart Team determines patient is a recommended candidate for the VDyne
System.
5. Age 18 years or older at time of the index procedure.
6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm
suitability for treatment with the VDyne System.
Exclusion criteria
VDYNE SYSTEM SUITABILITY
1. Patient anatomy (cardiac and vascular) is not suitable for the VDyne System
as assessed by Imaging Core Labs, Sponsor and/or Clinical Screening Committee
(CSC)
2. Intolerance to procedural anticoagulation or post-procedural
antiplatelet/anticoagulation regimen that cannot be medically managed
3. Hypersensitivity to nickel or titanium
CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
4. Left Ventricular Ejection Fraction (LVEF) <30%
5. Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus
7. Sepsis including active infective endocarditis (IE) (within the last 6
months)
8. Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
9. Severe tricuspid annular or leaflets calcification
10. Systolic pulmonary hypertension with systolic pulmonary artery pressure >70
mmHg or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.
11. History of rheumatic fever that impacts the native tricuspid valve or
surrounding structures.
CONCOMITANT PROCEDURES
12. Significant coronary artery disease requiring treatment such as
symptomatic, unresolved multi-vessel or unprotected left main coronary artery
disease
(CAD).
13. Any planned surgery or interventional procedure within 30 days prior to or
following the implant procedure. This includes any planned concomitant
cardiovascular procedure [e.g. Coronary Artery Bypass Grafting (CABG),
percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial
appendage occlusion, septal defect repair, etc.]
14. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
15. Cardiac resynchronization therapy device or implantable pulse generator
implanted within 60 days of planned implant procedure.
16. Permanent pacing leads that will interfere with delivery or implantation of
the VDyne Valve.
17. Cardiogenic shock or hemodynamic instability requiring inotropes or
mechanical support devices at the time of planned implant procedure.
18. Prior tricuspid valve surgery or catheter-based therapy with permanent
residual device(s) implanted that would preclude delivery or implantation of
the VDyne Valve (e.g. valve replacement, edge to edge repair, etc.)
19. Significant valvular heart disease requiring intervention other than the
tricuspid valve
20. Known significant intracardiac shunt [e.g. septal defect), patent foramen
ovales (PFOs) without significant shunts are allowed]
COMORBIDITIES
21. Cerebrovascular accident (stroke, TIA) within 6 months of treatment
procedure
22. Severe lung disease [severe chronic obstructive pulmonary disease (COPD) or
continuous use of home oxygen or oral steroids]
23. Acute myocardial infarction (AMI) within 30 days
24. Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis
25. End-stage liver disease (MELD > 11 and Child-Pugh class C)
26. Bleeding requiring transfusion within 30 days
27. Coagulopathy or other clotting disorder that cannot be medically managed
28. Chronic immunosuppression or other condition that could impair healing
response
29. Any of the following: leukopenia, chronic anemia [Hemoglobin (Hgb) < 9],
current thrombocytopenia (platelets <70), history of bleeding diathesis, or
coagulopathy
30. Unwilling to receive blood products
GENERAL EXCLUSION CRITERIA
31. Known hypersensitivity or contraindication to procedural or post-procedural
medications (e.g., contrast solution) which cannot be adequately managed
medically
32. Life expectancy less than 12 months due to non-cardiac comorbidities
33. Treatment is not expected to provide benefit (futile)
34. Current IV Drug user (must be free drug abuse for > 1 year)
35. Pregnant, lactating or planning pregnancy during the course of the study
36. Vulnerable patient groups (minors, cognitively impaired persons, prisoners,
persons whose willingness to volunteer could be unduly influenced by the
expectation of benefits associated with participation or of retaliatory
response from senior members of a hierarchy in case of refusal to participate,
such as students, residents, and employees)
37. Currently participating in an investigational drug or device trial that has
not reached its primary endpoint or is likely to interfere with this study
38. Patient (or legal guardian) unable or unwilling to provide written informed
consent before study-specific procedures are conducted
39. Patient unable or unwilling to comply with study required testing and
followup visits.
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 |
|---|---|
| Other | CIV-LT-21-04-036270 |
| CCMO | NL87616.000.24 |