CardioMEMS HF System OUS Post Market Study

Heart Failure Clinical Trial

Official title:

CardioMEMS HF System OUS Post Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954341
• Other study ID #: SJM-CIP-10147
• Status: Completed
• Start date: July 2016
• Est. completion date: December 8, 2023

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Left-Sided Heart Failure

Intervention

Device:
• CardioMEMS HF System

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside	Queensland
Belgium	CHR Citadelle	Liège
Denmark	Rigshospitalet	Copenhagen
France	CHRU de Lille	Lille
United Kingdom	Royal Bromptom Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device/system related complications		Two year
Primary	Freedom from pressure sensor failure.		Two year
Primary	Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment.		One year