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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Visits | Number of emergency department visits | Through study completion, an average of 1 year |
| Days alive outside the hospital | Days alive outside the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Contact | 469-814-4181 | Bonnie.Ostergren@bswhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano | Recruiting | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9960 | Background | 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. | |
| 26184 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Through study completion, an average of 1 year |
| 6067 | Background | 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. |
| 15767 | Background | 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. |