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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Atlantic Health System
Study ID
NCT07309029
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) — DEVICE
    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.

Study Details

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

Key Dates

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
May 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery. [ Time Frame: From enrollment through hospital discharge (up to 30 days post-procedure) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Structural Heart Disease Henry Ford HospitalDetroitMichigan48202
Pedro Villablanca, MD
[email protected]
(313) 916-2600
Valve and Structural Heart Center Morristown Medical CenterMorristownNew Jersey07960
Gennaro Giustino, MD
[email protected]
9739718858

Find similar trials in Detroit, MI

By research site
Center for Structural Heart Disease Henry Ford Hospital· Detroit, MIValve and Structural Heart Center Morristown Medical Center· Morristown, NJ

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