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Wireless Monitoring System
CardioMEMS Monitoring for Heart Failure
N/A
Waitlist Available
Led By Stavros Drakos, M.D.
Research Sponsored by STAVROS G DRAKOS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction <=25% and cardiomegaly at time of LVAD implantation
Severe clinical HF resistant to intensive medical therapy and requiring LVAD implantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will compare two different methods of managing heart failure patients with left ventricular assist devices.
Who is the study for?
This trial is for adults with severe heart failure who need an LVAD (heart pump) and have a body mass index of 35 or less. They must not be pregnant, agree to use contraception if of childbearing potential, and have had heart failure for less than 5 years. People with certain other health conditions or those participating in other heart-related trials cannot join.Check my eligibility
What is being tested?
The study compares two methods of managing patients with LVADs: the usual care versus a special wireless monitoring system called CardioMEMS that guides treatment based on detailed heart measurements. Participants will also receive standard medications aimed at improving the structure and function of the heart.See study design
What are the potential side effects?
While specific side effects are not listed, using CardioMEMS may include risks related to implanting the device like infection or bleeding. Standard HF medications can cause various side effects such as kidney problems, low blood pressure, electrolyte imbalances, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is very low and my heart was enlarged when I got my LVAD.
Select...
I need a heart pump implant due to severe heart failure not improved by medication.
Select...
My heart failure is not caused by reduced blood flow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects that meet explantation criteria by month 12 post-LVAD implantation, have LVAD explanted and retain left ventricular ejection fraction >=45% at 12 months post-LVAD weaning
Secondary outcome measures
Hospital Admissions
Six-minute Walk Test
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
After LVAD and wireless monitoring system (CardioMEMS) implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using CardioMEMS. During the Unloading phase, invasive hemodynamic guidance (via CardioMEMS) will be utilized to optimize pressure and volume unloading along with serial echocardiographic evaluations to assess for cardiac recovery, and LVAD explantation will be considered. After explantation, patients will undergo cardiac rehab and regular follow up with adjustments of HF medications based on the CardioMEMS-guided hemodynamic assessment.
Group II: ControlActive Control1 Intervention
After LVAD implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using echocardiographic imaging and other standard-of-care practices. During the Unloading phase, patients are serially evaluated with echocardiograms to assess for cardiac recovery, and LVAD explantation performed when predefined criteria are met. After explantation, patients undergo cardiac rehab and regular follow up.
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Who is running the clinical trial?
AbbottIndustry Sponsor
750 Previous Clinical Trials
478,290 Total Patients Enrolled
20 Trials studying Heart Failure
6,053 Patients Enrolled for Heart Failure
STAVROS G DRAKOSLead Sponsor
2 Previous Clinical Trials
600 Total Patients Enrolled
1 Trials studying Heart Failure
100 Patients Enrolled for Heart Failure
Stavros Drakos, M.D.Principal InvestigatorUniversity of Utah
1 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have needed dialysis in the last 3 months.You are allergic to aspirin or clopidogrel.I have a mechanical heart valve(s) implanted.You have a condition that may make you unlikely to live for at least 2 years.My organs are failing and cannot recover.My heart's pumping ability is very low and my heart was enlarged when I got my LVAD.I cannot take blood thinners or have a bleeding disorder.My heart's left chamber is smaller than normal.I have had a heart or other organ transplant.I need a heart pump implant due to severe heart failure not improved by medication.My heart failure is not caused by reduced blood flow.I have had a stroke that now limits my ability to move and exercise.I have a heart condition known as hypertrophic obstructive cardiomyopathy or sarcoidosis.You cannot handle a procedure called right heart catheterization.I had a heart device implanted less than 3 months ago.I am not part of any other studies involving heart failure treatments or devices.I have had more than one blood clot in my lungs or deep veins.I am of childbearing age, not pregnant, and agree to use birth control during the study.I was born with a heart condition.You have been diagnosed with acute myocarditis through a tissue biopsy.You had a heart pump implanted in the last 4 weeks, or you are planning to have one implanted.I currently have an infection.You have a problem with your aortic valve.The size of the pulmonary artery branch is between 7 to 15 millimeters.I was diagnosed with heart failure less than 5 years ago.You are not severely overweight, with a body mass index of 35 or lower.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers presently enrolling for this trial?
"As per data hosted on clinicaltrials.gov, this medical experiment is no longer seeking new participants; original posting was February 1st 2023 and the most recent edit occured September 1st 2022. On a brighter note, there are 701 other studies actively enrolling patients currently."
Answered by AI
Does this research project accept participants who are aged sixty and above?
"The eligible age range for this experiment is between 18 and 60. Alternatively, there are 22 trials open to minors and 691 available studies geared towards seniors over 65 years of age."
Answered by AI
Is it possible for me to participate in this research endeavor?
"This clinical study seeks 10 people who have experienced heart failure and are between 18-60 years old. To qualify, patients must have recently had or be scheduled for an LVAD implantation; manifesting severe HF that is unresponsive to medical therapy; possess a left ventricular ejection fraction no higher than 25%; exhibit cardiomegaly at the time of LVAD implantation; experience non-ischemic etiology of HF; report having suffered from HF for less than 5 years; and achieve a BMI below 35 kg/m^2."
Answered by AI
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