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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01288976
First received: January 25, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Mitral Valve (MV) Regurgitation
Device: MitraClip
Drug: Medical Management
Procedure: Mitral Valve Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe

Further study details as provided by Evalve:

Primary Outcome Measures:
  • Change from Baseline in Quality of Life at 12-month follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire will be used as a measure of the patients' perceptions of the effects of congestive heart failure on their lives.

  • Change from baseline in 6-minute walk distance test at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The 6-minute walk distance test will be used to measure the patient's exercise capacity.


Enrollment: 567
Study Start Date: October 2008
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Mitral Regurgitation

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288976

Locations
Germany
Universitatsmedizin Gottingen
Gottingen, Germany, 37075
Sponsors and Collaborators
Evalve
Investigators
Study Director: Barathi Sethuraman, PhD Abbott Vascular Structural Heart (Evalve Inc)
Principal Investigator: Wolfgang Schillinger, MD Universitatsmedizin Gottingen
Principal Investigator: Francesco Maisano, MD Fondazion Ctr San Raffaele Del Monte Tabor Istituto
  More Information

Additional Information:
Publications:

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01288976     History of Changes
Other Study ID Numbers: EU-0901
Study First Received: January 25, 2011
Last Updated: March 6, 2014
Health Authority: France: French Data Protection Authority
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Evalve:
Mitral Valve
Mitral Regurgitation
MitraClip
Mitral Valve Surgery
Mitral Valve Insufficiency or Mitral Regurgitation

ClinicalTrials.gov processed this record on September 30, 2014