The primary objective of the study is to generate safety and performance data for the CardiAQ* Transcatheter Mitral Valve Implant System with the Transapical Delivery System to support a future marketing application for the treatment of moderate to…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the percentage of Subjects with a composite Major
Adverse Event (MAE) at 30 days for the following events: cardiovascular
mortality, myocardial infarction, disabling stroke and conversion to surgery
per VARC definitions.
Secondary outcome
Safety Endpoints
* Freedom from composite MAE at three (3), six (6) and twelve (12) months
* Individual 30-Day event rates for the following: cardiovascular mortality,
procedure related death, non-cardiovascular mortality, myocardial infarction,
disabling stroke, non-disabling stroke, transient ischemic attack (TIA),
conversion to surgery, life-threatening, major and minor bleeding, stages 1-3
acute kidney injury and major and minor vascular complications per VARC
definitions
* Number of events and percentage of Subjects for all individual adverse events
related to the System or procedure at 30 days, three (3), six (6) and twelve
(12) months
Hemodynamic Efficacy
Hemodynamic improvement at 30 days, three (3), six (6) and twelve (12) months
compared to Baseline. The Bioprosthesis will be assessed by echocardiography
for reduction in mitral regurgitation by quantitative measures (e.g. PISA, vena
contracta width, EROA, regurgitant volume and fraction), as well as overall MR
grade.
Functional Improvements
Functional improvements at 30 days, three (3), six (6) and twelve (12) 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).
Acute Device/Procedural Success
Acute device/procedural success is defined as meeting all the following:
successful transapical access, successful delivery and deployment of the
Bioprosthesis and retrieval of the Catheter, correct positioning of the
Bioprosthesis at the proper anatomical location to achieve Grade 2+ or less MR
following the implant procedure, no clinically-significant LVOT obstruction
(pressure gradient * 20 mmHg) and no bleeding requiring re-intervention for
apical repair.
Background summary
Today*s standard of care for mitral valve replacement is open-heart surgery.
But, open-heart surgery can involve serious risks for patients who are older,
have other heart disease, or have general health problems.
CardiAQ Valve Technologies, Inc. has developed the CardiAQ TMVI System to
replace a patients mitral valve without the need for open-heart surgery.
Instead, the CardiAQ Valve is implanted using a procedure called a
transcatheter mitral valve implantation (TMVI)
Study objective
The primary objective of the study is to generate safety and performance data
for the CardiAQ* Transcatheter Mitral Valve Implant System with the Transapical
Delivery System to support a future marketing application for the treatment of
moderate to severe mitral valve regurgitation in patients who are considered
high or extreme risk for mortality and morbidity from conventional open heart
surgery.
Study design
Clinical safety and performance study - multi-center, prospective, single-arm,
non-randomized study without concurrent or historical controls
Intervention
Transcatheter Mitral Valve Implantation
Study burden and risks
As the CardiAQ TMVI System is an investigational device, there may also be
additional risks or side effects, which are unknown at this time. Possible
outcomes of these risks and side effects could include reoperation, surgical
removal of the device, permanent disability or death.
The information that is learned from this study may benefit other patients who
have your same health condition. It is possible that the collection of
information on the performance and safety of the device will allow early
detection of unforeseen problems.
The CardiAQ Valve may provide one or more of these benefits:
* Mitral valve replacement without open heart surgery
* Mitral regurgitation reduction or elimination that improves the blood flow
through your heart
* Improved quality of life by reducing some of your physical limitations
* Reduced discomfort or tiredness when performing certain physical activities
2 Jenner, Suite 100 2
Irvine CA 92618
US
2 Jenner, Suite 100 2
Irvine CA 92618
US
Listed location countries
Age
Inclusion criteria
General
1. * 65 years old.
2. Willing and able to comply with all required follow-up evaluations and assessments.
3. Subject or authorized representative has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study.
Heart Failure Status
4. New York Heart Associate Classification * III
5. Left Ventricular Ejection Fraction * 30%.
6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe) using the AHA/ACC 2014 Guidelines for the Management of Patients with Valvular Heart Disease (as published in Circulation March 3, 2014).
7. STS mortality score * 8% or determined to be high or extreme surgical risk by a Cardiac Surgeon.
8. Hemodynamically stable while on heart failure medication for at least 30 days before the procedure.
Anatomical
9. Left atrial height * 4 cm.
10. Left Ventricular End Systolic Diameter (LVESD) * 6 cm.
11. Mitral valve major (single axis) annulus diameter meets the range of 36-39.5 mm.
12. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator.
13. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator.
Exclusion criteria
General
1. Currently participating in another investigational drug or device study.
2. Need for emergent or urgent surgery for any reason.
3. Any condition that, in the opinion of the Investigator, could interfere with Subject participation, confound the study results or interfere with study compliance.
Anatomical
4. Lack of chordal support of the mitral valve (i.e., ruptured papillary muscle or secondary chords).
5. Severe calcification of any component of the mitral valve, including one or both of the mitral leaflets.
6. Myocardial infarction within the previous 6 weeks.
7. Intra-cardiac thrombus, mass or vegetation.
8. Need for native aortic or pulmonic valve replacement.
Existing Co-morbidities
9. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
10. Pre-existing mechanical prosthetic valve in the aortic position.
11. History of cardiac transplantation.
12. Any history of pulmonary embolism.
13. Clinically significant, untreated coronary artery disease.
14. Percutaneous coronary intervention within the prior 30 days.
15. Contraindication to Transesophageal/Transoesophageal Echocardiography (TEE/TOE).
16. Active endocarditis or rheumatic heart disease within the previous 3 months.
17. Refractory, unstable angina.
18. Significant cerebral vascular event within the previous 3 months.
19. Atrial fibrillation with uncontrolled heart rate (> 100 bpm).
20. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction, cardiogenic shock or the need for inotropic or intra-aortic balloon pump support).
21. Untreatable hypersensitivity or contraindication to any of the following:
* Aspirin and Clopidogrel and Ticlopidine, OR
* Heparin and Bivalirudin, OR
* Warfarin, Nitinol Alloys (nickel and titanium), contrast media, glutaraldehyde or bovine tissue.
22. Bleeding diathesis or coagulopathy, or Subject refuses blood transfusion.
23. Active peptic ulcer or GI bleeding.
24. Severe pulmonary hypertension (> 55 mmHg) and severe COPD (FEV1/FVC < 70% and FEV1 < 50% predicted FEV1).
25. Severe right ventricular systolic dysfunction.
26. Severe tricuspid valve regurgitation (Grade 4+)
27. Pulmonary function FEV1 (< 750 cc).
28. Subject has severe kidney disease with
* Creatinine level > 194 µmol/L (2.2 mg/dL) OR
* eGFR * 30 mL/min.
29. Liver disease, cirrhosis of the liver or significantly abnormal liver function test results.
30. Significant uncorrected endocrinology deficiency.
31. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
32. Active infections that requires antibiotic therapy (if temporary illness, Subjects may enroll 2 weeks after discontinuation of antibiotics). Subjects must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
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 |
|---|---|
| CCMO | NL52340.078.15 |