CardioMEMS for Heart Failure

(CALM Trial)

Overseen By Bonnie Ostergren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Aspirin, Clopidogrel

Disqualifiers: Liver cirrhosis, Renal disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a small device called CardioMEMS can reduce hospital visits for people with heart failure who have a Left Ventricular Assist Device (LVAD). The device, placed in the pulmonary artery, sends daily heart pressure readings to doctors. Doctors use this information to adjust treatment and improve heart health. The trial seeks participants with a well-functioning LVAD who are stable and ready to go home. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance heart failure management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CardioMEMS device is safe for heart failure patients?

Research has shown that the CardioMEMS device is safe for people with heart failure. Studies have found that it can reduce hospital visits by up to 62% for these patients. The device monitors pressure in the main artery of the lungs and the heart rate. The FDA has approved this device for certain heart failure patients, indicating it has passed strict safety tests for those groups.

Doctors place the CardioMEMS device in the lung's main artery during a heart procedure. Once in place, it sends information wirelessly to doctors, helping them adjust treatments based on up-to-date information. While any medical procedure carries some risks, this device has a good safety record. Overall, the CardioMEMS device is well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardioMEMS device because it offers a new way to monitor heart failure patients by directly measuring pulmonary artery pressure (PAP) in real-time. Unlike standard care, which relies on periodic echocardiograms and clinical assessments, the CardioMEMS device provides continuous hemodynamic data, allowing doctors to tailor treatments more precisely and potentially prevent hospitalizations. This approach could lead to improved heart failure management by enabling more proactive adjustments in therapy, based on the dynamic insights gathered from daily PAP readings.

What evidence suggests that the CardioMEMS device is effective for heart failure?

Research has shown that the CardioMEMS device, which participants in this trial may receive, can greatly reduce hospital visits for people with heart failure. In one study, patients experienced up to a 57% decrease in hospitalizations related to heart failure after using the device. It also helps lower pressure in the lungs' blood vessels, which is important for heart health. Another study found a 46% reduction in hospital stays just six months after receiving the CardioMEMS system. These benefits occur regardless of how well the heart pumps blood. Overall, the CardioMEMS device has demonstrated strong potential in effectively managing heart failure. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with heart failure who are receiving or have received a Left Ventricular Assist Device (LVAD). Participants should be eligible and willing to have the CardioMEMS device implanted. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am between 21 and 85 years old.

The patient provides written informed consent before starting any component of this clinical investigation

My heart pump device is working properly.

Exclusion Criteria

Inability to complete written informed consent or a quality-of-life questionnaire

I am currently experiencing fevers or general illness symptoms.

My bilirubin levels are high, or I have liver issues like shock liver or cirrhosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

CardioMEMS device is implanted and PAP measurements are taken daily. Adjustments to medical therapy and LVAD speed settings are made based on hemodynamic data.

12 months

Weekly data review

Control

Standard of care monitoring including periodic evaluations of echocardiographic parameters, clinical assessments, and quality of life assessments.

12 months

Periodic evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CardioMEMS Device

Trial Overview The CALM Study is testing if monitoring pulmonary artery pressure (PAP) with the CardioMEMS device can reduce hospitalizations due to heart failure in LVAD patients, compared to standard care without PAP monitoring.

How Is the Trial Designed?

Group I: Intervention Group: CardioMEMS Device Experimental Treatment 1 Intervention

For patients randomized to the intervention group, the CardioMEMS device will be implanted during a right heart catheterization procedure. The device will be positioned in the pulmonary artery and calibrated using a Swan-Ganz catheter. After implantation, PAP measurements will be taken daily using the home monitoring system provided to the patient. These readings will be transmitted wirelessly to the clinical team, who will review the data at least once per week. Adjustments to the patient's medical therapy and LVAD speed settings will be made based on the hemodynamic data provided by the CardioMEMS device.

Group II: Control Group: Standard of Care Monitoring Active Control 1 Intervention

Patients in the control group will be monitored according to standard of care, which includes periodic evaluations of echocardiographic parameters (e.g., left ventricular size and function, aortic and mitral valve function, and right ventricular function), clinical assessments (e.g., NYHA classification, medication review, and physical examination), quality of life assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ), functional status evaluations with a six-minute walk test, and monitoring for adverse events such as heart failure-related hospitalizations, reoperations, and device-related complications.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843804/

CardioMEMS Heart Failure System: An Up-to-Date Review In this trial, NYHA class III HF patients experienced improved quality of life and reduced hospitalizations (by 44%) when managed with the ...

2. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/heart-failure/pulmonary-pressure-monitors/cardiomems/clinical-evidence.html

CardioMEMS HF System Clinical Evidence At one year, results showed a reduction in pulmonary artery pressures and a 57% reduction in HFH regardless of ejection fraction. To date, trial exceeded the ...

3. innovationsincrm.com innovationsincrm.com/latest-news/998-cardiomems-hf-system

Late-Breaking Data Shows the CardioMEMS HF System is ... Researchers found a 46 percent reduction in heart failure hospitalizations in patients six months after receiving the CardioMEMS HF System, and a 34 percent ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006863

Lower Rates of Heart Failure and All-Cause ... Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. Conclusions: In ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1875213624003097

Results from the CardioMEMS HF System Post-Market ... The primary efficacy endpoint was evaluated comparing the rate of heart failure hospitalization during the year before and the year after implantation. Results.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100045S056B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure ...

7. jhltonline.org jhltonline.org/article/S1053-2498(22)00348-5/fulltext

Long Term Safety and Outcomes Utilizing the CardioMEMS ... Conclusion. The CardioMEMS device has previously been reported to reduce hospitalizations in patients with left sided heart failure. Based on our study, ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009116

Quantification of Device-Related Event Reports Associated ... CardioMEMS implantation rates have risen rapidly from 5500 in 2017 to 20 000 as of January 2021 and are expected to double after the recent ...