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CardioMEMS HF System OUS Post Market Study

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ClinicalTrials.gov Identifier: NCT02954341
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

Condition or disease Intervention/treatment
Heart Failure Left-Sided Heart Failure Congestive Heart Failure Device: CardioMEMS HF System

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CardioMEMS HF System OUS Post Market Study
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023



Primary Outcome Measures :
  1. Freedom from device/system related complications [ Time Frame: Two year ]
  2. Freedom from pressure sensor failure. [ Time Frame: Two year ]
  3. Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment. [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.
Criteria

Inclusion Criteria:

  1. Written informed consent obtained from subject
  2. ≥ 18 years of age
  3. Diagnosis of NYHA Class III Heart Failure
  4. At least 1 HF hospitalization within 12 months of Baseline visit
  5. Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB.
  6. Subjects with a BMI ≤ 35. Subjects with BMI >35 will require their chest circumference to be measured at the axillary level, if > 65 inches the patient will not be eligible for the study.
  7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
  8. Subjects willing and able to comply with the follow-up requirements of the study

Exclusion Criteria:

  1. Subjects with an active infection
  2. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
  4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
  5. Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to enrollment
  6. Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  7. Subjects with congenital heart disease or mechanical right heart valve(s)
  8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
  9. Subjects with known coagulation disorders
  10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).

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): NCT02954341


Contacts
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Contact: Maxime De Groof maxime.degroof@abbott.com
Contact: Poornima Sood Poornima.sood@abbott.com

Locations
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Australia, Queensland
The Prince Charles Hospital Active, not recruiting
Chermside, Queensland, Australia, 4032
Belgium
CHR Citadelle Recruiting
Liège, Belgium
Contact: Pierre Troisfontaines, MD         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Kasper Rossing, MD         
France
CHRU de Lille Active, not recruiting
Lille, France
United Kingdom
Royal Bromptom Hospital Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Martin R Cowie, MD Royal Brompton & Harefield NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02954341    
Other Study ID Numbers: SJM-CIP-10147
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases