Status:
UNKNOWN
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
Lead Sponsor:
Mvrx, Inc.
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Eligibility Criteria
Inclusion
- Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- Age ≥ 18
- Trans-septal catheterization is determined to be feasible by the treating physician
- NYHA class II-IV heart failure of any etiology
- Symptomatic with MR grade ≥ 2+
- LVEF ≥20% ≤ 50%
- LVEDD \> 50 mm and ≤ 70 mm
- No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
- • In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.
Exclusion
- In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
- Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
- Significant mitral annular calcification
- Hemodynamic instability (systolic pressure \< 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
- History of, or active, rheumatic heart disease
- History of Atrial Septal Defects (ASD), whether repaired or not
- History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
- In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
- Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02302872
Start Date
October 1 2013
End Date
September 1 2021
Last Update
April 28 2021
Active Locations (9)
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1
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
2
St Andrews Hospital
Adelaide, South Australia, Australia, 5000
3
Warringal Private Hospital
Heidelberg, Australia
4
The Mount Hospital
Perth, Australia