Cardiac Assist for Cardiogenic Shock and High Risk PCI - The Synchritude Registry

Cardiac Assist for Cardiogenic Shock and High Risk PCI - The Synchritude Registry - Synchritude Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028527

Enrollment

300

Registered

2022-07-26

Start date

2017-09-11

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

R57.0 I20 I22 I23 I25.1

Interventions

Group 1: One treatment arm of patients undergoing high-risk PCI (hrPCI) or suffering from cardiogenic shock (CS). All patients are studied at baseline and immediately after each patient is stabilized

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients treated with the i-COR® system had one of the following two medical problems: - Patients in cardiogenic shock or - Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, unprotected left main, or last patent conduit interventions) in the catheterization lab - Patient or legal caregiver has provided written consent prior to data collection. Cardiogenic shock was defined as: - Systolic blood pressure 90 mmHg or - Clinical signs of cardiac insufficiency with pulmonary congestion or - Signs of end organ hypoperfusion with at least one of the following criteria: - Altered mental status - cold, damp skin or extremities - oliguria (= 30 mL/h) - serum lactate > 2.0 mmol/L

Exclusion criteria

Exclusion criteria: Candidates are ineligible for enrollment in the study if any of the following conditions were identified at the screening or baseline visits: - Coma with fixed pupils not induced by drugs - Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) - Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters - Previous known aortic regurgitation greater than grade II - Contra-indications for anticoagulation - Severe hemolysis of any cause - Use of radio frequency surgical instruments - Use of a reservoir was prohibited

Design outcomes

Primary

Measure	Time frame
The purpose of this study is to perform post-market surveillance and evaluate prospectively the performance of the i-COR® SYNCHRONIZED CARDIAC ASSIST device in patients with cardiogenic shock or in patients undergoing high risk percutaneous intervention procedures in the catheterization lab.	—

Secondary

Measure	Time frame
no secondary endpoint	—

Countries

Germany

Contacts

Public ContactTorsten Rinne

Xenios AG

torsten.rinne@xenios-ag.com+49 7131 2706 193

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026