Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02607527
• Date of registration: 28/10/2015
• Prospective Registration: Yes
• Primary sponsor: Boston Scientific Corporation
• Public title: Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
• Scientific title: Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
• Date of first enrolment: May 8, 2017
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02607527
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Brazil, Paraguay

Contacts

• Name: Alexandre Abizaid, MD
• Affiliation: Dante Pazzanese de Cardiologia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Presence of symptomatic severe MR (effective regurgitant orifice (ERO) =0.2 cm2 for
Secondary MR, ERO =0.4 cm2 for Primary MR)

- The New York Heart Association Functional Class II, III or ambulatory IV.

- Left Ventricular Ejection Fraction (LVEF) is =20% and =50%

- Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory -Upper
Limit of Normal (ULN).

- Left Ventricular End Systolic Dimension (LVESD) is = 65 mm assessed by TTE obtained
within 90 days Exclusion Criteria: -Untreated clinically significant coronary artery
disease requiring revascularization.

Presence of any of the following:

- Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based
on echocardiography or right heart catheterization

- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or
any other structural heart disease causing heart failure other than dilated
cardiomyopathy of either ischemic or non-ischemic etiology

- Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)

- Hemodynamic instability requiring inotropic support or mechanical heart assistance.

- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without
afterload reduction, cardiogenic shock or the need for inotropic support or
intra-aortic balloon pump or other hemodynamic support device.

- Physical evidence of right-sided congestive heart failure with echocardiographic
evidence of moderate or severe right ventricular dysfunction.

- Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent.

- Percutaneous coronary intervention within 30 days prior to subject's consent.

- Tricuspid valve disease requiring surgery.

- Aortic valve disease requiring surgery or TAVI.

- Carotid surgery within 30 days prior to subject registration.

- Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac -Resynchronization
Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to
subject registration.

- Need for emergent or urgent surgery for any reason or any planned cardiac surgery
within the next 12 months.

- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve,
or any prior transcatheter mitral valve procedure.

- Status 1 heart transplant or prior orthotopic heart transplantation.

- Chronic Kidney Disease.

- Chronic Steroid Therapy.

- Cerebrovascular accident within 30 days prior to subject's consent.

- Severe symptomatic carotid stenosis (> 70% by ultrasound).Life expectancy < 12 months
due to non-cardiac conditions.

- Active infections requiring current antibiotic therapy.

- Pregnant or planning pregnancy within next 12 months.

- Currently participating in an investigational drug or another device study.

- Severe organic lesions with mitral chords retraction, severely fibrotic and immobile
leaflets, severely deformed subvalvular apparatus.

- endocarditis or active endocarditis in the last 3 months.

- Heavily calcified annulus or leaflets, mitral valve stenosis.

- Congenital malformation with limited valvular tissue

- Patient requires mitral valve replacement

- Previously implanted prosthetic mitral valve or annuloplasty ring/band.

- Evidence of LV or LA thrombus, vegetation or mass

- Left Ventricular Ejection Fraction <20%

- Left Ventricular End Diastolic Diameter >65 mm

- Severe tricuspid regurgitation or severe RV dysfunction

- Condition that prevents transatrial access or transfemoral access

- Anatomical ineligibility to the investigational device

- Known hypersensitivity or contraindication to procedural or post procedural medication
(e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or
titanium.



Age minimum: 30 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mitral Valve Insufficiency

Intervention(s)

Device: Mitral Valve IRIS Ring

Primary Outcome(s)

Acute Safety defined as incidence of adverse events [Time Frame: Procedure through 30 days post procedure]

Secondary Outcome(s)

Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo [Time Frame: Procedural through 48 hrs post procedure]

Secondary ID(s)

CP-002, CP-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors