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The MitraClip® EXPAND Study

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ClinicalTrials.gov Identifier: NCT03502811
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Abbott Medical Devices

April 11, 2018
April 19, 2018
November 7, 2018
April 26, 2018
February 1, 2019   (Final data collection date for primary outcome measure)
  • Occurrence of Major Adverse Events (MAE) [ Time Frame: up to 30 Days ]
    MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).
  • MR Reduction to ≤2+ [ Time Frame: At 30 days ]
    MR Severity of 2+ or less at 30 days
Same as current
Complete list of historical versions of study NCT03502811 on ClinicalTrials.gov Archive Site
  • No of participants with APS [ Time Frame: Up to 10 Days ]
    Acute Procedural Success (APS) defined as successful implantation of the MitraClip® device with resulting MR severity of 2+ or less on discharge Echocardiogram.
  • No of participants with ADS [ Time Frame: Up to 10 Days ]
    Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.
  • MR Reduction to ≤1+ [ Time Frame: At 30 Days ]
    MR Reduction to ≤1+ at 30 days
  • All Cause Mortality [ Time Frame: up to 30 Days ]
    All Cause Mortality Through 30 days
  • All Cause Mortality [ Time Frame: up to 6 Months ]
    All Cause Mortality Through 6 Months
  • All Cause Mortality [ Time Frame: up to 12 Months ]
    All Cause Mortality Through 12 Months
  • Heart Failure Hospitalization [ Time Frame: up to 30 Days ]
    Heart Failure Hospitalization Through 30 days
  • Heart Failure Hospitalization [ Time Frame: up to 6 Months ]
    Heart Failure Hospitalization Through 6 Months
  • Heart Failure Hospitalization [ Time Frame: up to 12 Months ]
    Heart Failure Hospitalization Through 12 Months
  • Occurrence of MAE [ Time Frame: At 30 Days ]
    Occurrence of Major Adverse Events (MAE) as defined in the protocol at 30 Days
  • Occurrence of MAE [ Time Frame: At 6 Months ]
    Occurrence of Major Adverse Events (MAE) as defined in the protocol at 6 Months
  • Occurrence of MAE [ Time Frame: At 12 Months ]
    Occurrence of Major Adverse Events (MAE) as defined in the protocol at 12 Months
  • Device Related Complications [ Time Frame: Up to 10 Days ]
    Device Related Complications as defined in the protocol at Discharge
  • Device Related Complications [ Time Frame: Up to 30 Days ]
    Device Related Complications as defined in the protocol at 30 Days
  • Device Related Complications [ Time Frame: Up to 6 Months ]
    Device Related Complications as defined in the protocol at 6 Months
  • Device Related Complications [ Time Frame: Up to 12 Months ]
    Device Related Complications as defined in the protocol at 12 Months
  • New York Heart Association (NYHA) functional class improvement [ Time Frame: Zero and 30 Days ]
    Difference Between NYHA Class at Baseline and 30Days
  • New York Heart Association (NYHA) functional class improvement [ Time Frame: Zero and 12 Months ]
    Difference Between NYHA Class at Baseline and 12 Months
  • Quality of Life (QOL) assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Zero and 30 Days ]
    Difference Between QOL at Baseline and 30 Days
  • Quality of Life (QOL) assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Zero and 12 Months ]
    Difference Between QOL at Baseline and 12 Months
Same as current
Not Provided
Not Provided
 
The MitraClip® EXPAND Study
A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Clinical outcomes and Echocardiographic measures will be assessed in the context of historical data.

The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required.

Up to 1,000 subjects at a maximum of 60 sites in Europe and the US will be in the MitraClip EXPAND Study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
This study will include patients who will undergo commercial procedures with the MitraClip® NTR System and/or MitraClip® XTR System after required approval of the device is obtained.
  • Mitral Valve Regurgitation
  • Mitral Regurgitation
Device: MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
Intervention: Device: MitraClip NTR/XTR System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
January 31, 2020
February 1, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects who give consent for study procedure
  2. Subjects eligible to receive the MitraClip per the current approved indications for use
  3. Subjects with Symptomatic MR (≥3+)

Exclusion Criteria:

1. Subjects participating in another clinical study that may impact the follow-up or results of this study

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Leslie Ornelas 408-306-7436 leslie.ornelas@abbott.com
Contact: Erin Tims 4089480736 erin.tims@abbott.com
Germany,   Italy,   Switzerland,   United States
 
 
NCT03502811
17-518
No
Not Provided
Not Provided
Abbott Medical Devices
Abbott Medical Devices
Abbott
Principal Investigator: Dr. Saibal Kar, MD Cedars Sinai, Los Angeles CA
Principal Investigator: Prof. Francesco Maisano, MD University Hospital, Zürich
Abbott Medical Devices
November 2018