PulseCath Mechanical Support Evaluatio
- Conditions
- heart diseaseIschemic cardiomyopathy10011082
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
1) No written informed consent
2) Left ventricular thrombus
3) Intervetricular septal defect
4) Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery.
5) Significant aortic valve disease (more than mild aortic stenosis/regurgitation)
6) Cardiogenic shock
7) Previous stroke within the last 3 months
8) Major bleeding event within last 3 months
9) Chronic kidney disease with a GFR < 25 mL/min
Criteria 10 to 12 are specific to the French site:
10) Women during pregnancy or lactation period according to the article L1121-5 of the CSP.
11) Vulnerable persons according to the article L.1121-6 of the CSP.
12) Persons subject to a legal protection measure or unable to express their consent according to Article L1121-8 of the CSP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pressure volume area (PVA) measurements will be taken at baseline, at<br /><br>successive regular time points during the LVAD use, at the end of the<br /><br>intervention, and after device removal. Impact on Myocardial Oxygen Consumption<br /><br>(MVO2) will be inferred from the PVA</p><br>
- Secondary Outcome Measures
Name Time Method