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Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
NCT07309029 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2027-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07309029
The ClinicalTrials.gov registry entry for NCT07309029 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07309029 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Michigan, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07309029?
The interventions under investigation include: Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07309029?
This trial is sponsored by Atlantic Health System, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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