CardioMEMS for Heart Failure
(CardioClip Trial)
Recruiting in Palo Alto (17 mi)
Overseen byNir Uriel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must not be taking: Aspirin, Clopidogrel
Disqualifiers: Congenital heart disease, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves monitoring heart function to adjust medications, it's possible that some changes might be needed. Please discuss this with the trial team for more details.
What data supports the effectiveness of the CardioMEMS treatment for heart failure?
Research shows that the CardioMEMS device can improve quality of life and reduce hospitalizations for people with heart failure by monitoring heart-related pressures remotely. However, there are concerns about its effectiveness in certain patient groups, and more studies are needed, especially in Europe, to confirm its benefits.
12345Is the CardioMEMS system safe for use in humans?
The CardioMEMS system is generally considered safe for use in heart failure patients, as noted by the FDA panel in 2011. However, there are potential risks during the sensor placement, such as injury to the pulmonary artery, which can lead to bleeding.
23467How is the CardioMEMS treatment different from other heart failure treatments?
The CardioMEMS treatment is unique because it involves an implantable wireless sensor placed in the pulmonary artery to remotely monitor pressure, allowing for proactive management of heart failure and reducing hospitalizations, unlike traditional treatments that are often reactive.
12348Eligibility Criteria
The CardioClip study is for individuals with heart failure and mitral valve regurgitation. Participants should be suitable for the non-surgical insertion of a wireless sensor through a vein in the groin, similar to mTEER procedure.Inclusion Criteria
I have moderate to severe secondary mitral regurgitation.
My heart's pumping ability is reduced but not severely impaired.
I experience mild to severe heart symptoms.
+1 more
Exclusion Criteria
I was born with a complex heart condition.
My heart's left ventricle is not larger than 70 mm when contracted.
My pulmonary artery pressure is 70 mmHg or less.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo mitral transcatheter edge-to-edge repair (mTEER) and receive a wireless pulmonary artery pressure sensor
1 week
1 visit (in-person)
Monitoring
Continuous monitoring of heart function using the implanted sensor to optimize medication
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Regular follow-up visits at 1, 6, and 12 months
Participant Groups
This trial tests a wireless sensor called CardioMEMS that monitors pulmonary artery pressure. It's inserted via the groin and sends heart function data so doctors can adjust treatments promptly based on real-time information.
2Treatment groups
Experimental Treatment
Active Control
Group I: CardioMemsExperimental Treatment1 Intervention
Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.
Group II: Usual CareActive Control1 Intervention
Participants randomized to this arm will receive usual care involving GDMT.
CardioMEMS is already approved in United States for the following indications:
🇺🇸 Approved in United States as CardioMEMS HF System for:
- Heart failure management in NYHA Class II and III patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
AbbottIndustry Sponsor
References
Current Role of the CardioMEMS Device for Management of Patients with Heart Failure. [2020]Heart failure (HF) remains a significant burden to our healthcare system and a leading cause of hospitalizations. Current reactive strategies to treat and manage HF have failed to reduce hospitalizations and improve survival. The CardioMEMS device has recently been demonstrated to improve quality of life in HF and reduce HF-related hospitalizations. Current HF management strategies are reviewed with a particular emphasis on the current role of the CardioMEMS device.
Implantable devices for heart failure monitoring: the CardioMEMS™ system. [2020]Several devices have been developed for heart failure (HF) treatment and monitoring. Among device-based monitoring tools, CardioMEMS™ has received growing research attention. This document reflects the key points of an ESC consensus meeting on implantable devices for monitoring in HF, with a particular focus on CardioMEMS™.
Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. [2019]The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.
Large pulmonary artery pseudoaneurysm after CardioMEMS implantation: a case report. [2022]CardioMEMS heart failure (HF) system is an implantable wireless pressure sensor that is placed in a branch of the pulmonary artery (PA) for remote monitoring of PA pressures in patients with HF. Pulmonary artery injury/haemoptysis can occur during the sensor placement.
The CardioMEMS Heart Failure System for chronic heart failure - a European perspective. [2023]Label="INTRODUCTION" NlmCategory="UNASSIGNED">Chronic heart failure (HF) is characterized by high hospital admission rates. The CardioMEMSTM HF System is a pulmonary artery pressure sensor developed for remote hemodynamic monitoring to reduce HF hospitalizations. The device is FDA approved and CE marked, but clinical evidence for the CardioMEMS system is mainly based upon U.S. studies. Because of structural differences in HF care between the U.S. and Europe, it is important to study CardioMEMS efficacy in European setting on top of usual HF care and contemporary therapy. Several observational studies have been performed in Europe, but there is an unmet need for randomized clinical trials.
Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. [2022]The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia.
The CardioMEMS Heart Failure Sensor: A Procedural Guide for Implanting Physicians. [2017]The CardioMEMS heart failure system is a recent Food and Drug Administration approved device that can be implanted in patients with New York Heart Association class III heart failure and allows remote monitoring of pulmonary artery pressures. There is limited published information regarding the implantation procedure. Successful use of the CardioMEMS heart failure system requires an understanding of the technical issues surrounding the implantation procedure. The goal of the present review is to provide a summary of the implantation procedure, discuss the required imaging steps, review procedural supplies, and present a series of case studies to illustrate clinically relevant issues that may arise during sensor implantation.
Understanding adherence to the CardioMEMS pulmonary artery pressure monitoring system for heart failure: A qualitative study. [2020]The CardioMEMS HF system is a remote monitoring device that allows patients to transmit pulmonary artery pressure readings to providers, who are alerted when pressures increase above the patient's normal threshold.