Clinical trial NCT01288976: ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
Official title: ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve (MV) Regurgitation
Keywords: Mitral Valve
Mitral Regurgitation
MitraClip
Mitral Valve Surgery
Mitral Valve Insufficiency or Mitral Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 721
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Mitral Regurgitation

Brief summary: 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.

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 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.

Primary outcomes:
measure: MR Severity
timeFrame: At baseline
measure: MR Severity
timeFrame: At 12 months
Secondary outcomes:
measure: Procedure Time
timeFrame: Day 0 (On the day of procedure)
measure: Contrast Volume
timeFrame: Day 0 (On the day of procedure)
measure: Fluoroscopy Duration
timeFrame: Day 0 (On the day of procedure)
measure: Number of MitraClip Devices Implanted
timeFrame: Day 0 (On the day of procedure)
measure: ICU and Hospital Stay
timeFrame: From the day of procedure throughout 12 months of study period
measure: Discharge Status and Facility
timeFrame: At discharge, an average of 7.7 days following the MitraClip procedure
measure: Discharge MR Severity
timeFrame: At discharge, an average of 7.7 days following the MitraClip procedure
measure: Kaplan-Meier Freedom From All-Cause Mortality
timeFrame: At 0 day
measure: Kaplan-Meier Freedom From All-Cause Mortality
timeFrame: At 30 days
measure: Kaplan-Meier Freedom From All-Cause Mortality
timeFrame: At 6 months
measure: Kaplan-Meier Freedom From All-Cause Mortality
timeFrame: At 12 months
measure: Device Embolization and Single Leaflet Device Attachment
timeFrame: Through 12 months
measure: 1-Day Post-Procedure Safety Outcomes
timeFrame: On day 1 post procedure
measure: Need for Mitral Valve Surgery
timeFrame: Through 12 months
measure: NYHA Functional Class
timeFrame: At baseline
measure: NYHA Functional Class
timeFrame: At 12 month
measure: The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
timeFrame: Baseline and 12 months
measure: Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
timeFrame: 12 months
measure: Six Minute Walk Test Distance (6MWT)
timeFrame: Baseline
measure: Six Minute Walk Test Distance (6MWT)
timeFrame: 12 months
Other outcomes:
Locations:
city: Gottingen
country: Germany
facility: Universitatsmedizin Gottingen
Study officials:
affiliation: Abbott Vascular Structural Heart (Evalve Inc)
name: Barathi Sethuraman, PhD
role: STUDY_DIRECTOR
affiliation: Universitatsmedizin Gottingen
name: Wolfgang Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazion Ctr San Raffaele Del Monte Tabor Istituto
name: Francesco Maisano, MD
role: PRINCIPAL_INVESTIGATOR
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