PulseCath Mechanical Support Evaluation

PulseCath Mechanical Support Evaluation - PULSE trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47268

Enrollment

Registered

2019-03-22

Start date

2017-01-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart disease Ischemic cardiomyopathy

Interventions

High risk percutaneous coronary interventions will be conducted in patients selected for the study in conformity with the previously mentioned criteria. Interventions conducted in Rotterdam (NL), To

High risk PCI

Percutaneous Left Ventricular Support

Pressure Volume Loop

PulseCath

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Signed Informed Consent form Patient older than 18 years Clinical criteria: The multidisciplinary heart team has reached consensus for high-risk PCI. Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation. Specific to the French site: Affiliation to Health Insurance

Exclusion criteria

Exclusion criteria: 1) No written informed consent 2) Left ventricular thrombus 3) Intervetricular septal defect 4) Significant peripheral arterial disease or arterial lumen size

Design outcomes

Primary

Measure	Time frame
Pressure volume area (PVA) measurements will be taken at baseline, at successive regular time points during the LVAD use, at the end of the intervention, and after device removal. Impact on Myocardial Oxygen Consumption (MVO2) will be inferred from the PVA	—

Secondary

Measure	Time frame
Hemodynamic assessment: Cardiac Output (CO), Cardiac Index (CI), End-Expiratory Mean Pulmonary Capillary Wedge Pressure (PCWP), PCWP v-wave (vPCWP), Mean Pulmonary Artery Pressure (mPAP), Left ventricle (LV) volumes and pressure during the cardiac cycle, PV area (PVA), Preload Recruitable Stroke Work (PRSW), Systolic and Diastolic Wall Stress (WSes and WSed), Starling Contractile Index (SCI). Total Systemic Resistance (TSR), Total Pulmonary Resistance (TPR), Cardiac Power Output (CPO). Blood samples: Hematocrit, Hemoglobine, Platelet Count, Haptoglobin, hs-Troponin, CK, CK-MB mass assay, NTpro-BNP, Serum Lactate, LDH, Total and Conjugated Bilirubin, Serum Creatinine. Transthoracic Echocardiography: LVEDD, LVESD, LVEDV, LVESV, IVSTd, PWTd, EF, degree of mitral regurgitation, Trans-Aortic Gradient, aortic regurgitation, trans-mitral diastolic inflow pattern, tissue Doppler E/e*, Tricuspid Regurgitation indicators including TR signal, and IVC assessment.	—

Measure

Time frame

Hemodynamic assessment: Cardiac Output (CO), Cardiac Index (CI), End-Expiratory Mean Pulmonary Capillary Wedge Pressure (PCWP), PCWP v-wave (vPCWP), Mean Pulmonary Artery Pressure (mPAP), Left ventricle (LV) volumes and pressure during the cardiac cycle, PV area (PVA), Preload Recruitable Stroke Work (PRSW), Systolic and Diastolic Wall Stress (WSes and WSed), Starling Contractile Index (SCI). Total Systemic Resistance (TSR), Total Pulmonary Resistance (TPR), Cardiac Power Output (CPO). Blood samples: Hematocrit, Hemoglobine, Platelet Count, Haptoglobin, hs-Troponin, CK, CK-MB mass assay, NTpro-BNP, Serum Lactate, LDH, Total and Conjugated Bilirubin, Serum Creatinine. Transthoracic Echocardiography: LVEDD, LVESD, LVEDV, LVESV, IVSTd, PWTd, EF, degree of mitral regurgitation, Trans-Aortic Gradient, aortic regurgitation, trans-mitral diastolic inflow pattern, tissue Doppler E/e*, Tricuspid Regurgitation indicators including TR signal, and IVC assessment.

—

Countries

France, Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)