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Trial record 1 of 1 for:    MEMS HF
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CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF)

This study is currently recruiting participants.
Verified June 2016 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02693691
First Posted: February 29, 2016
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Condition Intervention
Heart Failure Device: CardioMEMS HF System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CardioMEMS European Monitoring Study for Heart Failure

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • freedom from device/system related complications [ Time Frame: one year ]
  • freedom from pressure sensor failure [ Time Frame: one year ]
  • % successful pulmonary artery pressure data transmissions [ Time Frame: one year ]

Secondary Outcome Measures:
  • HF hospitalization rate [ Time Frame: one year ]

Estimated Enrollment: 230
Study Start Date: May 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardioMEMS HF System
Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.
Device: CardioMEMS HF System
Pulmonary Artery Pressure Monitoring

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
  • > 18 years of age
  • Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
  • Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
  • Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
  • Written informed consent obtained from subject

Exclusion Criteria:

  • Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
  • Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693691


Contacts
Contact: Pascale Dardenne 003227746887 pdardenne@sjm.com
Contact: Tamara Shipman 0014085226410 tshipman@sjm.com

Locations
Germany
Klinukum Coburg Recruiting
Coburg, Bavaria, Germany, 96450
Contact: Johannes Brachmann, Prof. Dr med         
Universitätsklinikum Würzburg Not yet recruiting
Würzburg, Bavaria, Germany, 97080
Contact: Peter Nordbeck, PD Dr. med.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christiane Angermann, Prof. Dr. Deutsches Zentrum für Herzinsuffizienz Würzburg
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02693691     History of Changes
Other Study ID Numbers: SJM-CIP-10105
First Submitted: February 20, 2016
First Posted: February 29, 2016
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases