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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 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.
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
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (95% lower). The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation.
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.
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