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CardioMEMS HF System OUS Post Market Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02954341
Collaborator
(none)
300
Enrollment
5
Locations
89
Anticipated Duration (Months)
60
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: CardioMEMS HF System

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
CardioMEMS HF System OUS Post Market Study
Actual Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Freedom from device/system related complications [Two year]

  2. Freedom from pressure sensor failure. [Two year]

  3. Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment. [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Prince Charles Hospital Chermside Queensland Australia 4032
2 CHR Citadelle Liège Belgium
3 Rigshospitalet Copenhagen Denmark
4 CHRU de Lille Lille France
5 Royal Bromptom Hospital London United Kingdom

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Chair: Martin R Cowie, MD, Royal Brompton & Harefield NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02954341
Other Study ID Numbers:
  • SJM-CIP-10147
First Posted:
Nov 3, 2016
Last Update Posted:
Apr 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 4, 2022