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NCT07309029 · ClinicalTrials.gov registry record

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

A clinical trial of Cardiogenic Shock and Severe Aortic Stenosis, sponsored by Atlantic Health System.

Recruiting
Registry status
30
Enrollment target
2
Study locations

NCT07309029: Recruiting study of Cardiogenic Shock and Severe Aortic Stenosis, sponsored by Atlantic Health System.

NCT07309029 is a study of Cardiogenic Shock and Severe Aortic Stenosis that is actively recruiting participants, run by Atlantic Health System. The registered enrollment target is 30 participants, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07309029, a study of Cardiogenic Shock and Severe Aortic Stenosis, is actively recruiting participants, sponsored by Atlantic Health System.

RECRUITING
Registry status
30 participants
Enrollment target
2
Study locations

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 Studied

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

Interventions

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

Study Locations (2)

Michigan

  • Center for Structural Heart Disease Henry Ford Hospital - Detroit

New Jersey

  • Valve and Structural Heart Center Morristown Medical Center - Morristown

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-01-01
Est. Completion 2027-06-30
Atlantic Health System

43 total trials

What NCT07309029 shows while recruiting

NCT07309029 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (95% lower).

The record links to 4 conditions, with Cardiogenic Shock appearing as the primary indexed condition, and to 1 intervention - of which Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) is the first listed.

NCT07309029 reports a single indexed study location in Michigan, New Jersey.

Frequently Asked Questions

What is clinical trial NCT07309029 about?

NCT07309029 is a clinical study titled "Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR". 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...

What is the current status of trial NCT07309029?

This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2026-01-01. Estimated completion is 2027-06-30.

What conditions does trial NCT07309029 study?

This clinical trial studies the following conditions: Cardiogenic Shock, Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Cardiogenic Shock, ECMO.

What interventions are being tested in trial NCT07309029?

The interventions under investigation include: Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) (DEVICE).

Who is sponsoring clinical trial NCT07309029?

This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07309029 being conducted?

This trial has 2 study locations across Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07309029's enrollment target sits among peer trials

30 13th of 16 higher than 4 of 16 other Cardiogenic Shock trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiogenic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07309029

Source: ClinicalTrials.gov NCT07309029, the US trial registry maintained by the National Library of Medicine. NCT07309029 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.