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Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR

NCT07309029 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-12-30

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are:

1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?
2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group.

Participants will:

* Be screened for eligibility based on hemodynamic status and anatomical complexity
* Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR
* Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography

Conditions

  • Severe Aortic Stenosis
  • Cardiogenic Shock
  • Cardiogenic Shock, ECMO
  • Trans-catheter Aortic Valve Implantation

Interventions

DEVICE

Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)

Pre-emptive use of LAVA-ECMO involves transseptal cannulation of the left atrium to provide mechanical circulatory support and left ventricular unloading during high-risk transcatheter aortic valve replacement (TAVR). The device is placed prior to or at the start of the TAVR procedure in patients with unstable hemodynamics or complex anatomical features.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-05-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309029 on ClinicalTrials.gov