ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe (ACCESS-EU)

November 5, 2018 updated by: Abbott Medical Devices
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PHASE I:

The primary objective of ACCESS-EU Phase I is to gain information in the European Union Countries regarding the use of the MitraClip System with respect to health economics and clinical care.

PHASE II: (HAS BEEN CLOSED BY SPONSOR) The primary objective of ACCESS-EU Phase II is to gather additional clinical data, specifically Echocardiography Core Laboratory measurements of MR severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the MitraClip procedure in the European Union Countries,

Clinical data collected from both study phases, is expected to contribute to decision making with regards to MitraClip therapy selection in patients with MR: (a) by establishing the value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions.

Study Design:

ACCESS-Europe is a two-phase prospective, observational, multicenter post-approval study of the MitraClip System for the treatment of mitral regurgitation (MR) in the European Union Countries. Patients will be evaluated per standard practice at baseline, discharge, 6-Months and 12-Months.

Phase I of the study consists of patients who receive the MitraClip system for the treatment of MR and two concurrent comparator groups of (a) medically managed heart failure patients with MR and (b) patients who have undergone mitral valve surgery for MR. The two comparator groups will be followed and evaluated primarily from a health economic perspective.

ACCESS EU Study Phase II will consist of only patients who receive the MitraClip System, with the objective to collect additional clinical data, specifically Echocardiography Core Laboratory evaluation of MR severity and other echocardiographic measures.

Enrollment of patients in each study phase is as follows:

ACCESS-EU PHASE I:

  • A minimum of 300 MitraClip Therapy group patients,
  • A minimum of 100 patients in the Mitral Valve Surgery comparator group
  • As many patients as possible in the Medical Therapy comparator group

First Patient Enrollment Projection: Q1, 2009 Last Patient Enrollment Projection: Enrollment in the Mitral Valve Surgery and Medically Therapy groups ceased on December 31, 2010. Enrollment in the MitraClip group will cease when Phase II of the study is initiated at each site.

ACCESS-EU PHASE II:

A minimum of 300 MitraClip therapy subjects will be enrolled in Phase II.

First Patient Enrollment Projection: Q2, 2011 Last Patient Enrollment Projection: Enrollment will cease when the Sponsor has determined that an adequate number of patients have been enrolled.

Study Type

Observational

Enrollment (Actual)

721

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gottingen, Germany, 37075
        • Universitätsmedizin Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Mitral Regurgitation

Description

Inclusion Criteria:

  • Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.

Exclusion Criteria:

  • Per the current approved labeling for the CE Marked MitraClip System.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip Therapy
Patients treated with the MitraClip System.
Device: MitraClip
The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
Medical Management
Patients with MR managed non-surgically based on standard hospital clinical practice.
Drug: Medical Management
The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included
Mitral Valve Surgery
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice.
Procedure: Mitral Valve Surgery
The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR Severity
Time Frame: At baseline

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported.
At baseline
MR Severity
Time Frame: At 12 months

MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: Day 0 (On the day of procedure)
Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Day 0 (On the day of procedure)
Contrast Volume
Time Frame: Day 0 (On the day of procedure)
Day 0 (On the day of procedure)
Fluoroscopy Duration
Time Frame: Day 0 (On the day of procedure)
Day 0 (On the day of procedure)
Number of MitraClip Devices Implanted
Time Frame: Day 0 (On the day of procedure)
Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis.
Day 0 (On the day of procedure)
ICU and Hospital Stay
Time Frame: From the day of procedure throughout 12 months of study period
ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.
From the day of procedure throughout 12 months of study period
Discharge Status and Facility
Time Frame: At discharge, an average of 7.7 days following the MitraClip procedure
At discharge, an average of 7.7 days following the MitraClip procedure
Discharge MR Severity
Time Frame: At discharge, an average of 7.7 days following the MitraClip procedure
At discharge, an average of 7.7 days following the MitraClip procedure
Kaplan-Meier Freedom From All-Cause Mortality
Time Frame: At 0 day
At 0 day
Kaplan-Meier Freedom From All-Cause Mortality
Time Frame: At 30 days
At 30 days
Kaplan-Meier Freedom From All-Cause Mortality
Time Frame: At 6 months
At 6 months
Kaplan-Meier Freedom From All-Cause Mortality
Time Frame: At 12 months
At 12 months
Device Embolization and Single Leaflet Device Attachment
Time Frame: Through 12 months

Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.

Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements.
Through 12 months
1-Day Post-Procedure Safety Outcomes
Time Frame: On day 1 post procedure
This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported.
On day 1 post procedure
Need for Mitral Valve Surgery
Time Frame: Through 12 months
This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure.
Through 12 months
NYHA Functional Class
Time Frame: At baseline

New York Heart Association (NYHA) Functional Classification.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased.
At baseline
NYHA Functional Class
Time Frame: At 12 month

Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased.
At 12 month
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
Time Frame: Baseline and 12 months
The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline.
Baseline and 12 months
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
Time Frame: 12 months

The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.

The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).
12 months
Six Minute Walk Test Distance (6MWT)
Time Frame: Baseline
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
Baseline
Six Minute Walk Test Distance (6MWT)
Time Frame: 12 months
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Barathi Sethuraman, PhD, Abbott Vascular Structural Heart (Evalve Inc)
  • Principal Investigator: Wolfgang Schillinger, MD, Universitätsmedizin Göttingen
  • Principal Investigator: Francesco Maisano, MD, Fondazion Ctr San Raffaele Del Monte Tabor Istituto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (ESTIMATE)

February 3, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EU-0901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Valve (MV) Regurgitation

Clinical Trials on MitraClip

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe