CALM Study: Cardiomems Assisted Lvad Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CardioMEMS Device.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 21 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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 b
Primary outcome measures
- Heart failure related (HFR) hospitalizations [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Baylor Scott & White The Heart Hospital - Plano — Plano
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. PMID 9960
- Hamar 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. PMID 26184
- Im 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. PMID 6067
- Collins 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. PMID 15767
Identifiers
NCT: NCT07096544 · 025-422