Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO) - APOLLO Trial

Medtronic Japan Co., Ltd0 sites1,350 target enrollmentOctober 7, 2019

ConditionsModerate-to-severe or severe symptomatic mitral regurgitation

Overview

Phase: 未知
Intervention: Not specified
Conditions: Moderate-to-severe or severe symptomatic mitral regurgitation
Sponsor: Medtronic Japan Co., Ltd
Enrollment: 1350
Status: Suspended
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 7, 2019

End Date

May 22, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Medtronic Japan Co., Ltd

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Refer Protocol for details. 1\. Estimated life expectancy of less than 24 months due to associated non\-cardiac comorbid conditions 2\. Currently implanted mitral valve 3\. Prior transcatheter mitral valve procedure with device currently implanted 4\. Anatomic contraindications for Intrepid TMVR System (e.g., annular dimensions, high risk of LVOT obstruction, system access, etc. 5\. Anatomically prohibitive mitral annular calcification (MAC) 6\. Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment 8\. Moderate or greater tricuspid regurgitation with echocardiographic evidence of significantly impaired right ventricular function as assessed by the echo core lab 12\. Left ventricular ejection fraction (LVEF) \<30% measured by resting transthoracic echocardiogram 14\. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than dilated ischemic or non\-ischemic cardiomyopathy 17\. Need for emergent or urgent cardiac or non\-cardiac surgery 18\. Hemodynamic instability requiring dependency of either inotropic agents or mechanical circulatory support 26\. Untreated clinically significant coronary artery disease requiring revascularization 32\. End stage renal disease requiring chronic dialysis or creatinine clearance \< 45 cc/min within 30 days of the Index Procedure 33\. Liver failure (Child\-Pugh\-C) 34\. Any Cancer requiring active treatment or with life expectancy less than 24 months 35\. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1\) \< 750cc, continuous home oxygen therapy, or chronic outpatient oral steroid use 36\. Frailty assessments 39\. Severe dementia