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The combination of VA-ECMO and percutaneous left ventricular assist device (pLVAD) in patients with cardiogenic shock (CS): A single-center, single-arm study

The combination of VA-ECMO and percutaneous left ventricular assist device (pLVAD) in patients with cardiogenic shock (CS): A single-center, single-arm study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088800
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Critical cardiovascular diseases

Interventions

Experimental group:Combined use of pLVAD on the basis of VA-ECMO support

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-80 years with cardiogenic shock who have been treated with VA-ECMO, and the VA-ECMO is running smoothly, but the patient with situation of left ventricular overload (frequent episodes of acute left heart failure, invasive arterial pressure difference <10mmHg, limited aortic valve opening, left ventricular blood stasis, etc.) The definition of cardiogenic shock includes: (1) hypotension: SBP<90mmHg or MAP <60mmHg, or the need for vasoactive drugs to maintain SBP=90mmHg or MAP =60mmHg; (2) low cardiac output (despite adequate preload); (3) Tissue hypoperfusion: altered mental status, clammy or spotted limbs, oliguria or anuria, and elevated lactate level.

Exclusion criteria

Exclusion criteria: (1)CPR; (2) severe pulmonary embolism; (3) severe right heart failure; (4) left ventricular wall thrombosis; (5) Ventricular septum or atrial septal defect; (6) cardiac rupture; (7) Pericardial tamponade; (8) Severe aortic valve disease: severe aortic regurgitation; severe aortic stenosis; severe aortic valve calcification; mechanical aortic valves; (9) Severe aortic disease: aortic dissection, etc.; (10) Severe peripheral vascular disease that makes it impossible for the experimental product to intervene; (11) History of chronic cardiopulmonary diseases; (12) It has a cardiac contraction regulator; (13) Hematologic diseases that can easily lead to hemolysis; (14) pregnancy; (15) Other circumstances judged by the investigator to be unsuitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
30-day survival rate after hospital discharge;

Secondary

MeasureTime frame
Successful weaning rate of VA-ECMO;Successful weaning rate of pLVAD;In-hospital survival rate;Survival rate at 3 months after discharge;Survival rate at 6 months after discharge;Survival rate at 1 year after discharge;The success rate of bridging to long-term therapy (long-term VAD or heart transplant);Incidence of hemolysis;transfusion;Incidence of bleeding;Vascular complication rate;Incidence of lower extremity ischemia;Incidence of ischemic stroke;Incidence of renal failure or CRRT;

Countries

China

Contacts

Public ContactMing Bai

The First Hospital of Lanzhou University

baiming@vip.163.com+86 138 9322 0909

Outcome results

None listed

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