Heart FailureCALMNCT07096544
CALM Study: Cardiomems Assisted Lvad Management
A study testing CardioMEMS Device in people with Heart Failure, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CardioMEMS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-85
- Status post HeartMate III Left Ventricular Assist Device Implantation
- Normally functioning left ventricular assist device as determined by device parameters
- Stable and ready to be discharged home
- 18 years of age or older at the time of left ventricular device implantation
- The patient provides written informed consent before starting any component of this clinical investigation
Who cannot join
- Current/ongoing fevers or constitutional symptoms
- Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis
- Requiring dialysis or declared end stage renal disease
- Inability to complete written informed consent or a quality-of-life questionnaire
- Known active malignancy
- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Show all 15Show fewer
- Unable to tolerate a right heart catheterization
- Major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of CardioMEMS implant
- Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy
- Patients likely to undergo heart transplantation within 6 months of Screening Visit
- Congenital heart disease or mechanical right heart valve(s)
- Known coagulation disorders
- Hypersensitivity or allergy to aspirin, and/or clopidogrel
- Pregnant or considering pregnancy
- Required RV assist device and has severe right heart failure post LVAD implantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
Bonnie Ostergren, 469-814-4181, Bonnie.Ostergren@bswhealth.org
About this study
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.
Read the detailed description
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.
Secondary objectives:
- Number of emergency department visits
- Days alive outside the hospital
- Rate of all cause rehospitalizations
- Change in NYHA functional class
- Impact on quality of life as determined by utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- Impact on functional status as determined by a six-minute walk test
- Rate of LVAD and CardioMEMS device malfunctions
- Change in baseline pulmonary pressures
- Rate and method of mortality
- Conditions
- Heart Failure
- Being tested
- CardioMEMS Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: CardioMEMS Device | Experimental | 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. Receives: Device: CardioMEMS Device |
| Control Group: Standard of Care Monitoring | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure related (HFR) hospitalizations
Rate of heart failure related (HFR) hospitalizations in LVAD patients whose PAP is monitored with the CardioMEMS device vs the control patients receiving standard of care treatment.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Emergency Visits
Number of emergency department visits
Measured: Through study completion, an average of 1 year
Days alive outside the hospital
Days alive outside the hospital
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start8 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096544
- Sponsor's protocol ID
- 025-422
- Acronym
- CALM
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Leff JP. Assessment of drugs in schizophrenia. Br J Clin Pharmacol. 1976 Feb;3(1 Suppl 1):75-8. doi: 10.1111/j.1365-2125.1976.tb03718.x. No abstract available.
PubMed 9960Hamar J, Ligeti L, Kovach AG. Intestinal O2 consumption under low flow conditions in anaesthetized cats. Adv Exp Med Biol. 1977 Jul 4-7;94:573-8. doi: 10.1007/978-1-4684-8890-6_77. No abstract available.
PubMed 26184Im WB, Christensen HN, Sportes B. Amino acid stimulation of ATP cleavage by two Ehrlich cell membrane preparations in the presence of ouabain. Biochim Biophys Acta. 1976 Jun 17;436(2):424-37. doi: 10.1016/0005-2736(76)90205-4.
PubMed 6067Collins MW, French MR, Hirom PC, Idle JR, Bassir O, Williams RT. The conjugation of benzoic acid in the African bat, Epomops franqueti. Comp Biochem Physiol C Comp Pharmacol. 1977;56(2):103-4. doi: 10.1016/0306-4492(77)90021-1. No abstract available.
PubMed 15767
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALM Study: Cardiomems Assisted Lvad Management
- ClinicalTrials.gov ID
- NCT07096544
- Acronym / sponsor ID
- CALM / 025-422
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Secondary objectives:
- Number of emergency department visits
- Days alive outside the hospital
- Rate of all cause rehospitalizations
- Change in NYHA functional class
- Impact on quality of life as determined by utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- Impact on functional status as determined by a six-minute walk test
- Rate of LVAD and CardioMEMS device malfunctions
- Change in baseline pulmonary pressures
- Rate and method of mortality
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: CardioMEMS Device | Experimental | Device: CardioMEMS DeviceFor 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. |
| Control Group: Standard of Care Monitoring | No 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 may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21-85
- Status post HeartMate III Left Ventricular Assist Device Implantation
- Normally functioning left ventricular assist device as determined by device parameters
- Stable and ready to be discharged home
- 18 years of age or older at the time of left ventricular device implantation
Key exclusion criteria (15 listed)
- Current/ongoing fevers or constitutional symptoms
- Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis
- Requiring dialysis or declared end stage renal disease
- Inability to complete written informed consent or a quality-of-life questionnaire
- Known active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioMEMS DeviceThe 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. | Device | Intervention Group: CardioMEMS Device |
Primary outcome
Heart failure related (HFR) hospitalizations
Time frame: Through study completion, an average of 1 year
Rate of heart failure related (HFR) hospitalizations in LVAD patients whose PAP is monitored with the CardioMEMS device vs the control patients receiving standard of care treatment.
2 secondary outcomes
Emergency Visits
Time frame: Through study completion, an average of 1 year
Days alive outside the hospital
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 9960Leff JP. Assessment of drugs in schizophrenia. Br J Clin Pharmacol. 1976 Feb;3(1 Suppl 1):75-8. doi: 10.1111/j.1365-2125.1976.tb03718.x. No abstract available.
- Background: PubMed 26184Hamar J, Ligeti L, Kovach AG. Intestinal O2 consumption under low flow conditions in anaesthetized cats. Adv Exp Med Biol. 1977 Jul 4-7;94:573-8. doi: 10.1007/978-1-4684-8890-6_77. No abstract available.
- Background: PubMed 6067Im WB, Christensen HN, Sportes B. Amino acid stimulation of ATP cleavage by two Ehrlich cell membrane preparations in the presence of ouabain. Biochim Biophys Acta. 1976 Jun 17;436(2):424-37. doi: 10.1016/0005-2736(76)90205-4.
- Background: PubMed 15767Collins MW, French MR, Hirom PC, Idle JR, Bassir O, Williams RT. The conjugation of benzoic acid in the African bat, Epomops franqueti. Comp Biochem Physiol C Comp Pharmacol. 1977;56(2):103-4. doi: 10.1016/0306-4492(77)90021-1. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioMEMS Device in people with Heart Failure, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie Ostergren (469-814-4181, Bonnie.Ostergren@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure related (HFR) hospitalizations (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096544, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.