Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial (APOLLO-EU)
Primary Purpose
Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Intrepid™ TMVR TF System
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation focused on measuring mitral, valve, regurgitation, TMVR, Intrepid™, symptomatic, severe
Eligibility Criteria
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
- 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
Sites / Locations
- RigshospitaletRecruiting
- Clinique PasteurRecruiting
- CHU BordeauxRecruiting
- Henri-Mondor University HospitalRecruiting
- Centre Cardiologique du Nord (CCN)Recruiting
- CHRU de ToursRecruiting
- Universitätsspital BernRecruiting
- University Hospitals Sussex NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medtronic Intrepid™ TMVR TF System
Arm Description
Medtronic Intrepid™ TMVR TF System
Outcomes
Primary Outcome Measures
Safety: all-cause mortality at 1-year post-procedure.
Rate of all-cause mortality at 1-year post-procedure.
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.
Secondary Outcome Measures
Rate of all-cause mortality (Safety).
Rate of all-cause mortality at 30 days post-procedure.
Disabling stroke (Safety).
Rate of disabling stroke at 30 days post-procedure.
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.
Reoperation or reintervention (Safety).
Rate of reoperation or reintervention at 30 days post-procedure.
Major access site vascular complications (Safety).
Number of major access site vascular complications at 30 days post-procedure.
Mitral valve regurgitation (Efficacy).
Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
NYHA functional class (Efficacy).
Change in NYHA functional class at 1 year (Efficacy).
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.
Cardiovascular hospitalizations (Efficacy).
Cardiovascular hospitalizations through 1 year (Efficacy).
Full Information
NCT ID
NCT05496998
First Posted
August 5, 2022
Last Updated
September 26, 2023
Sponsor
Medtronic Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT05496998
Brief Title
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
March 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation 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.
Detailed Description
Prospective, single-arm, multi-center, interventional, pre-market trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
mitral, valve, regurgitation, TMVR, Intrepid™, symptomatic, severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects with moderate-to-severe or severe symptomatic mitral regurgitation who by agreement of the heart team experienced in mitral valve therapies are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medtronic Intrepid™ TMVR TF System
Arm Type
Experimental
Arm Description
Medtronic Intrepid™ TMVR TF System
Intervention Type
Device
Intervention Name(s)
Medtronic Intrepid™ TMVR TF System
Intervention Description
Patients with moderate-to-severe or severe symptomatic mitral regurgitation will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System
Primary Outcome Measure Information:
Title
Safety: all-cause mortality at 1-year post-procedure.
Description
Rate of all-cause mortality at 1-year post-procedure.
Time Frame
1 year
Title
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Description
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality (Safety).
Description
Rate of all-cause mortality at 30 days post-procedure.
Time Frame
30 days
Title
Disabling stroke (Safety).
Description
Rate of disabling stroke at 30 days post-procedure.
Time Frame
30 days
Title
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
Description
Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Time Frame
30 days
Title
Reoperation or reintervention (Safety).
Description
Rate of reoperation or reintervention at 30 days post-procedure.
Time Frame
30 days
Title
Major access site vascular complications (Safety).
Description
Number of major access site vascular complications at 30 days post-procedure.
Time Frame
30 days
Title
Mitral valve regurgitation (Efficacy).
Description
Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
Time Frame
1 year
Title
NYHA functional class (Efficacy).
Description
Change in NYHA functional class at 1 year (Efficacy).
Time Frame
1 year
Title
Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).
Description
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.
Time Frame
1 year
Title
Cardiovascular hospitalizations (Efficacy).
Description
Cardiovascular hospitalizations through 1 year (Efficacy).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Gonnissen, PhD
Phone
+31 (0)43 356 6566
Email
rs.apolloeurope@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Modine, Prof.
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
von Bardeleben, Prof.
Organizational Affiliation
University Medical Center Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Lund Kuipers
Phone
+45(0)35456485
Email
sofie.lund.kuipers@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ole de Backer, Prof.
First Name & Middle Initial & Last Name & Degree
Jacob Møller, Prof.
Facility Name
Clinique Pasteur
City
Toulouse
State/Province
Cedex 03
ZIP/Postal Code
31076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Petit
Phone
+33(0)562213186
Email
fpetit@clinique-pasteur.com
First Name & Middle Initial & Last Name & Degree
Didier Tchétché, Dr.
First Name & Middle Initial & Last Name & Degree
Pierre Berthoumieu, Dr.
Facility Name
CHU Bordeaux
City
Bordeaux
State/Province
Pessac Cedex
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Vincent
Phone
+33(0)556795679
Email
aurelie.vincent@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Thomas Modine, Prof.
First Name & Middle Initial & Last Name & Degree
Lionel Leroux, Dr.
Facility Name
Henri-Mondor University Hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte Bidaud
Phone
+33(0)149812265
Email
brigitte.chevalier-bidaud-ext@aphp.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel Teiger, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Thierry Folliguet, Prof. Dr.
Facility Name
Centre Cardiologique du Nord (CCN)
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karima Moussouni
Phone
+33(0)149334141
Email
k.moussouni@ccn.fr
First Name & Middle Initial & Last Name & Degree
Mohammed Nejjari, Dr.
First Name & Middle Initial & Last Name & Degree
Nicolas Bonnet, Dr.
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céleste Verne
Phone
+33(0)247476913
Email
c.verne@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Alexandra Bonnet
Phone
+33(0)247476913
Email
a.bonnet@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Christophe Saint Etienne, Dr.
First Name & Middle Initial & Last Name & Degree
Thierry Bourguignon, Prof.
Facility Name
Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Moro
Phone
+41(0)316324476
Email
christina.moro@insel.ch
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, Prof.Dr.med.
First Name & Middle Initial & Last Name & Degree
David Reineke, Dr. med.
Facility Name
University Hospitals Sussex NHS Foundation Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Parker
Phone
+44(0)1273696955
Ext
67950
Email
jessica.parker21@nhs.net
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, Prof.
First Name & Middle Initial & Last Name & Degree
Uday Trivedi, Mr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
We'll reach out to this number within 24 hrs