Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Mitral Regurgitation Clinical Trial

— APOLLO-EU  

Official title:

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496998
• Other study ID #: MDT22008TMV005
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: December 2038

Study information

• Verified date: May 2024
• Source: Medtronic Cardiovascular
• Contact: Hanne Gonnissen, PhD
• Phone: +31 (0)43 356 6566
• Email: rs.apolloeurope[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Description:

Prospective, single-arm, multi-center, interventional, pre-market trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2038
• Est. primary completion date: August 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC

• Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery

• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

• Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion Criteria:

• Estimated life expectancy of less than 24 months

• Currently surgically implanted mitral valve

• Prior transcatheter mitral valve procedure with device currently implanted

• Anatomic contraindications

• Anatomically prohibitive mitral annular calcification (MAC)

• Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment

• LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)

• Left ventricular end diastolic diameter (LVEDD) > 75mm

• Need for emergent or urgent surgery

• Hemodynamic instability

• History of bleeding diathesis or coagulopathy

• End stage renal disease

• Liver failure

• Frailty

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Medtronic Intrepid™ TMVR TF System
Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	CHU Bordeaux	Bordeaux	Pessac Cedex
France	Henri-Mondor University Hospital	Créteil
France	CHU Timone	Marseille
France	Centre Cardiologique du Nord (CCN)	Saint-Denis
France	Clinique Pasteur	Toulouse	Cedex 03
France	CHRU de Tours	Tours
Germany	Heart and Diabetes Center NRW	Bad Oeynhausen
Germany	Deutsches Herzzentrum der Charité (DHZC)	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitäres Herz- und Gefäßzentrum Hamburg	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	University Medical Center Mainz	Mainz
Germany	Deutsches Herzzentrum München	München
Germany	LMU Clinic of University Hospital München	München
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus University Medical Center	Rotterdam
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Central University Hospital of Asturias	Oviedo
Switzerland	Universitätsspital Bern	Bern
United Kingdom	University Hospitals Sussex NHS Foundation Trust	Brighton
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: all-cause mortality at 1-year post-procedure.	Rate of all-cause mortality at 1-year post-procedure.	1 year
Primary	Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.	Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.	30 days
Secondary	Rate of all-cause mortality (Safety).	Rate of all-cause mortality at 30 days post-procedure.	30 days
Secondary	Disabling stroke (Safety).	Rate of disabling stroke at 30 days post-procedure.	30 days
Secondary	Acute Kidney Injury (stage 3 or with renal replacement) (Safety).	Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.	30 days
Secondary	Reoperation or reintervention (Safety).	Rate of reoperation or reintervention at 30 days post-procedure.	30 days
Secondary	Major access site vascular complications (Safety).	Number of major access site vascular complications at 30 days post-procedure.	30 days
Secondary	Mitral valve regurgitation (Efficacy).	Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.	1 year
Secondary	NYHA functional class (Efficacy).	Change in NYHA functional class at 1 year (Efficacy).	1 year
Secondary	Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).	Change of Quality of Life (QoL) at 1 year as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.	1 year
Secondary	Cardiovascular hospitalizations (Efficacy).	Cardiovascular hospitalizations through 1 year (Efficacy).	1 year