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High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy (HiRiDe)

Primary Purpose

Mitral Valve Insufficiency

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
MitraClip®
Mitral valve Surgery
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring MitraClip®, MR, DMR, high-risk patients, mitral regurgitation, surgery, intermediate risk patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gender: Both, male and female
  • Minimum Age: 18 Years
  • Maximum Age: no maximum age
  • Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR
  • NYHA Functional Class III or IV
  • Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement)
  • Subjects meet the following conditions:

Age >18 and high or intermediate risk patients with an STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors

  • patient is operable
  • Signed by the subject and dated approved informed consent prior to any study related procedure
  • Available and able to return to study site for post-procedural follow-up examination

Exclusion Criteria:

  • Patient incapable to approve the informed consent or Emergency Cases
  • functional mitral valve pathology
  • evolving endocarditis or active endocarditis in the last 3 months
  • heavily calcified leaflets
  • subjects in whom transesophageal echocardiography is contraindicated
  • subjects in whom transseptal catheterisation is contraindicated
  • presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
  • currently participating in the study of an investigational drug or device
  • untreated clinically significant CAD requiring revascularisation
  • any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
  • prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
  • concomitant and significant aortic or tricuspid valve pathology
  • CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound)
  • contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication

Sites / Locations

  • Universitätsklinikum Bonn
  • Asklepios Klinik Hamburg St. Georg
  • Universitäres Herzzentrum Hamburg GmbH
  • Universitätsklinikum Köln, Herzzentrum
  • Klinikum der Universität München Großhadern
  • Helios Klinikum Siegburg
  • Presidio Ospedaliero Ferrarotto Alessi
  • San Raffaele Hospital
  • Policlinico Tor Vergata
  • Inselspital Bern
  • Fondazione Cardiocentro Ticino
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MitraClip® Therapy

Surgery

Arm Description

MitraClip® system is a CE marked medical device, which consists of two parts (Clip Delivery System and Steerable Guide Catheter). It is a single sized, percutaneously implanted mechanical Clip. The MitraClip® device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The procedure is performed in the cardiac catheterisation laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anaesthesia.

Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard

Outcomes

Primary Outcome Measures

30-day safety superiority (ITT analysis): Major Adverse Event Composite
The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days.
12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group
The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery).

Secondary Outcome Measures

Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
Evaluation of all SAEs and SADEs that occur during the trial
MR Severity reduction at 6 and 12 month
MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
NYHA class changes at 6 and 12 months
NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
Change in 6MWT in 6 and 12 month
Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
Change in Quality of Life in 6 and 12 months
Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
Heart failure hospitalisation rate
Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
Days alive and out of hospital
Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
Hospital resources utilisations
Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services
Change in Quality of Life (SF36) in 6 and 12 months
Change in SF36 at 1,6 and 12 month in the MitraClip® and Surgery groups

Full Information

First Posted
August 6, 2015
Last Updated
September 8, 2016
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02534155
Brief Title
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy
Acronym
HiRiDe
Official Title
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).
Detailed Description
Two-arm, multi-centre, randomised prospective study comparing MitraClip® to Surgical therapy in high and intermediate risk patients. Patients should be older than 18 years and high and intermediate risk is defined by a score (for MV repair) >= 3% and <= 10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors. Patients are selected upon clinical conditions and severity of MR. Anatomical feasibility is assessed by ECHO, according to the IFU (information for use). The purpose of the trial is to evaluate safety and efficacy of MitraClip® vs. surgery in high and intermediate risk patients with DMR. Study Follow-Up includes the following visits after procedure: Hospital discharge, 1, 6, 12 months post-procedure. Primary Endpoints are the 30-day safety superiority (ITT analysis) and the 12-month efficacy non-inferiority (ITT analysis) of the MitraClip®. The overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) until 12 months and the MR Severity reduction at 6 and 12 month in the MitraClip® and Surgery groups are Secondary Endpoints

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
Keywords
MitraClip®, MR, DMR, high-risk patients, mitral regurgitation, surgery, intermediate risk patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitraClip® Therapy
Arm Type
Active Comparator
Arm Description
MitraClip® system is a CE marked medical device, which consists of two parts (Clip Delivery System and Steerable Guide Catheter). It is a single sized, percutaneously implanted mechanical Clip. The MitraClip® device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The procedure is performed in the cardiac catheterisation laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anaesthesia.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Surgical therapy of degenerative mitral regurgitation: repair or replacement of mitral valve, clinical standard
Intervention Type
Device
Intervention Name(s)
MitraClip®
Intervention Description
one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
Intervention Type
Procedure
Intervention Name(s)
Mitral valve Surgery
Intervention Description
Repair or replace mitral valve
Primary Outcome Measure Information:
Title
30-day safety superiority (ITT analysis): Major Adverse Event Composite
Description
The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days.
Time Frame
30 days
Title
12-month efficacy non-inferiority (ITT analysis): Proportion of responders in the Device vs. the Surgery group
Description
The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery).
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) within 12 month
Description
Evaluation of all SAEs and SADEs that occur during the trial
Time Frame
12 month
Title
MR Severity reduction at 6 and 12 month
Description
MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups
Time Frame
between 6 and 12 month
Title
NYHA class changes at 6 and 12 months
Description
NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups
Time Frame
between 6 and 12 month
Title
Change in 6MWT in 6 and 12 month
Description
Change in 6MWT (6 Minute Walking Test) in 6 and 12 months in the MitraClip® and Surgery groups
Time Frame
between 6 and 12 months
Title
Change in Quality of Life in 6 and 12 months
Description
Change in Quality of Life (MLWHF) at 1,6 and 12 month in the MitraClip® and Surgery groups
Time Frame
between 1 and 12 months
Title
Heart failure hospitalisation rate
Description
Heart failure hospitalisation rate in the post randomisation in the MitraClip® and Surgery groups
Time Frame
during 12 months post procedure
Title
Days alive and out of hospital
Description
Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups
Time Frame
during 12 months post procedure
Title
Hospital resources utilisations
Description
Hospital resources utillizations: length of stay post-procedure, ICU beds occupancy, need for rehabilitation services
Time Frame
during 12 months post procedure
Title
Change in Quality of Life (SF36) in 6 and 12 months
Description
Change in SF36 at 1,6 and 12 month in the MitraClip® and Surgery groups
Time Frame
between 1 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR NYHA Functional Class III or IV Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement) Subjects meet the following conditions: Age >18 and high or intermediate risk patients with an STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors patient is operable Signed by the subject and dated approved informed consent prior to any study related procedure Available and able to return to study site for post-procedural follow-up examination Exclusion Criteria: Patient incapable to approve the informed consent or Emergency Cases functional mitral valve pathology evolving endocarditis or active endocarditis in the last 3 months heavily calcified leaflets subjects in whom transesophageal echocardiography is contraindicated subjects in whom transseptal catheterisation is contraindicated presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year currently participating in the study of an investigational drug or device untreated clinically significant CAD requiring revascularisation any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure concomitant and significant aortic or tricuspid valve pathology CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound) contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Maisano, Prof.
Organizational Affiliation
Universitätspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Asklepios Klinik Hamburg St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Köln, Herzzentrum
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum der Universität München Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Helios Klinikum Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Presidio Ospedaliero Ferrarotto Alessi
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Fondazione Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy

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