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CALM Study: Cardiomems Assisted Lvad Management

NCT07096544 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-13

No results posted yet for this study

Summary

This prospective, open label, randomized, single-center pilot clinical trial will determine if the rate of heart failure related (HFR) hospitalizations is less in LVAD patients whose PAP is monitored with the CardioMEMS device vs the control patients receiving standard of care treatment.

Conditions

Interventions

DEVICE

CardioMEMS Device

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.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2027-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096544 on ClinicalTrials.gov