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

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ClinicalTrials.gov Identifier: NCT01288976
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : December 18, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Evalve

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Mitral Valve (MV) Regurgitation
Interventions: Device: MitraClip
Drug: Medical Management
Procedure: Mitral Valve Surgery

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The ACCESS-EU Phase I Study began enrolling patients in October 2, 2008 and completed enrollment on April 13, 2011. There were 567 patients enrolled at 14 investigational sites in Europe. The last follow-up visit occurred on June 15, 2012 and the last monitoring visit occurred August 9, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MitraClip Therapy

Patients treated with the MitraClip System.

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 nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically 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. 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.

Participant Flow:   Overall Study
    MitraClip Therapy   Medical Management   Mitral Valve Surgery
STARTED   567   49   105 
COMPLETED   389   22   85 
NOT COMPLETED   178   27   20 
Withdrawal by Subject                58                12                9 
Death                98                6                4 
Data unavailable                22                9                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MitraClip Therapy

Patients treated with the MitraClip System.

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 nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically 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. 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.
Total Total of all reporting groups

Baseline Measures
   MitraClip Therapy   Medical Management   Mitral Valve Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 567   49   105   721 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.7  (9.6)   70.7  (12.6)   60.0  (15.2)   68.1  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      205  36.2%      23  46.9%      46  43.8%      274  38.0% 
Male      362  63.8%      26  53.1%      59  56.2%      447  62.0% 
Region of Enrollment 
[Units: Participants]
       
Europe   567   49   105   721 


  Outcome Measures

1.  Primary:   MR Severity   [ Time Frame: At baseline ]

2.  Primary:   MR Severity   [ Time Frame: At 12 months ]

3.  Secondary:   Procedure Time   [ Time Frame: Day 0 (On the day of procedure) ]

4.  Secondary:   Contrast Volume   [ Time Frame: Day 0 (On the day of procedure) ]

5.  Secondary:   Fluoroscopy Duration   [ Time Frame: Day 0 (On the day of procedure) ]

6.  Secondary:   Number of MitraClip Devices Implanted   [ Time Frame: Day 0 (On the day of procedure) ]

7.  Secondary:   ICU and Hospital Stay   [ Time Frame: From the day of procedure throughout 12 months of study period ]

8.  Secondary:   Discharge Status and Facility   [ Time Frame: At discharge, an average of 7.7 days following the MitraClip procedure ]

9.  Secondary:   Discharge MR Severity   [ Time Frame: At discharge, an average of 7.7 days following the MitraClip procedure ]

10.  Secondary:   Kaplan-Meier Freedom From All-Cause Mortality   [ Time Frame: At 0 day ]

11.  Secondary:   Kaplan-Meier Freedom From All-Cause Mortality   [ Time Frame: At 30 days ]

12.  Secondary:   Kaplan-Meier Freedom From All-Cause Mortality   [ Time Frame: At 6 months ]

13.  Secondary:   Kaplan-Meier Freedom From All-Cause Mortality   [ Time Frame: At 12 months ]

14.  Secondary:   Device Embolization and Single Leaflet Device Attachment   [ Time Frame: Through 12 months ]

15.  Secondary:   1-Day Post-Procedure Safety Outcomes   [ Time Frame: On day 1 post procedure ]

16.  Secondary:   Need for Mitral Valve Surgery   [ Time Frame: Through 12 months ]

17.  Secondary:   NYHA Functional Class   [ Time Frame: At baseline ]

18.  Secondary:   NYHA Functional Class   [ Time Frame: At 12 month ]

19.  Secondary:   The Change in 6 Minute Walk Test Distance From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

20.  Secondary:   Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months   [ Time Frame: 12 months ]

21.  Secondary:   Six Minute Walk Test Distance (6MWT)   [ Time Frame: Baseline ]

22.  Secondary:   Six Minute Walk Test Distance (6MWT)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey T Ellis
Organization: Abbott Vascular
e-mail: jeffrey.ellis@av.abbott.com


Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01288976     History of Changes
Other Study ID Numbers: EU-0901
First Submitted: January 25, 2011
First Posted: February 3, 2011
Results First Submitted: November 3, 2016
Results First Posted: December 18, 2017
Last Update Posted: April 6, 2018