CardioMEMS HF System Post Approval Study

Heart Failure Clinical Trial

Official title:

CardioMEMS HF System Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279888
• Other study ID #: SJM-CIP-10035
• Status: Completed
• Start date: January 2015
• Est. completion date: October 11, 2019

Study information

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

Clinical Trial Summary

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Description:

The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of NYHA class III heart failure

• At least 1 heart failure hospitalization within previous 12 months

• Patients 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 patient is intolerant to beta blockers, ACE-I or ARB

• BMI = 35. Patients 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.

• Pulmonary artery branch diameter = 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:

• Active infection

• History of recurrent (> 1) pulmonary embolism or deep vein thrombosis

• Inability to tolerate a right heart catheterization

• A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months

• Cardiac resynchronization device (CRT) implanted within previous 3 months

• Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis

• Congenital heart disease or mechanical right heart valve

• Likely to undergo heart transplantation or VAD within the next 6 months

• Known coagulation disorders

• Hypersensitivity or allergy to aspirin, and/or clopidogrel

Related Conditions & MeSH terms

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

Intervention

Device:
• CardioMEMS HF System
Pulmonary artery pressure sensor

Locations

Country	Name	City	State
United States	West Virginia Heart Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method.	one and two years
Other	Heart Failure Hospitalization or Death Rate	The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met.	one year
Other	Patient Compliance	Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings	One and Two Years
Other	Training Evaluation - Freedom From DRSC in Academic and Community Hospitals	To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.	2 Years
Other	Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals	To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.	2 Years
Other	Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals	To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.	2 Years
Primary	Freedom From Device and/or System Related Complication (DSRC)	As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.	two years
Primary	Freedom From Pressure Sensor Failure	A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.	two year
Primary	Heart Failure Hospitalization (HFH) Rate	Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.	one year