CardioMEMS European Monitoring Study for Heart Failure

NCT02693691 | Completed Results

• 1 other identifier: SJM-CIP-10105
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Heart Failure Hospitalization (HFH) Rate

  one year

Study Arms (1)

CardioMEMS HF System

EXPERIMENTAL

Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.

Device: CardioMEMS HF System

Interventions

CardioMEMS HF System DEVICE

Pulmonary Artery Pressure Monitoring

CardioMEMS HF System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Klinukum Coburg

Coburg, Bavaria, 96450, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (3)

• Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.

  PMID: 40223608 DERIVED

• Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4.

  PMID: 34738340 DERIVED

• Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.

  PMID: 29777373 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Marie-Elena Brett
• Organization: Abbott

marieelena.brett@abbott.com

7815283613

Study Officials

• Christiane Angermann, Prof. Dr.

  Deutsches Zentrum für Herzinsuffizienz Würzburg

  PRINCIPAL INVESTIGATOR

• Michael Boehm, Prof. Dr.

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2016
• First Posted: February 29, 2016
• Study Start: May 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: March 1, 2020
• Last Updated: April 5, 2022
• Results First Posted: August 14, 2020

Record last verified: 2022-04

Locations

DE (2)