CardioMEMS European Monitoring Study for Heart Failure

Heart Failure Clinical Trial

— MEMS-HF  

Official title:

CardioMEMS European Monitoring Study for Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693691
• Other study ID #: SJM-CIP-10105
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: March 1, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CardioMEMS HF System
Pulmonary Artery Pressure Monitoring

Locations

Country	Name	City	State
Germany	Klinukum Coburg	Coburg	Bavaria
Germany	Universitätsklinikum Würzburg	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Device/System Related Complications	This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as 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 cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.	one year
Primary	Freedom From Pressure Sensor Failure	This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.	one year
Primary	Percent of Successful Pulmonary Artery Pressure Data Transmissions	Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.	one year
Secondary	Heart Failure Hospitalization (HFH) Rate	Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant.	one year