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NCT Number: NCT07309029

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 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

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Key information

Conditions

Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiogenic Shock Cardiogenic Shock, ECMO Cardiovascular Diseases Heart Diseases Heart Valve Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Trans-catheter Aortic Valve Implantation Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Structural Heart Disease Henry Ford Hospital, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).
  • Hemodynamic Criteria
  • Major Criteria (Class III)
  • Systolic blood pressure <90 mmHg or MAP<60 mmHg
  • Need for vasopressors or inotropes to maintain MAP>60 mmHg
  • Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation
  • Minor Criteria (Class II)
  • Left ventricular ejection fraction <35%
  • Pulmonary hypertension (pulmonary artery systolic pressure >60 mmHg) with right ventricular dysfunction
  • Pulmonary capillary wedge pressure >30 mmHg
  • Anatomic criteria
  • Major Criteria (Type C)
  • Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)
  • Native or valve-in-valve TAVR requiring dual-leaflet modification
  • Severe bioprosthetic aortic regurgitation
  • Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score >33)
  • Minor Criteria (Type B)
  • Native or valve-in-valve TAVR requiring single-leaflet modification
  • Severe commissural misalignment requiring leaflet modification
  • High-risk for coronary occlusion not amenable to leaflet modification
  • Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)

Exclusion criteria

  • Age <18 or pregnant
  • General absolute contraindications to TAVR
  • Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.
  • Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).
  • Pre-existing Impella treatment.
  • Onset of shock >12 hours.
  • Preceding cardiac arrest with prolonged resuscitation (>40 minutes).
  • Other severe concomitant disease with life expectancy <6 months.
  • Participation in another trial with an intervention.
  • Any class I hemodynamic status
  • Type A anatomical complexity with class I or II hemodynamic status

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Primary Safety Endpoint: Composite of VARC-3 major vascular complications, type 3 or 4 VARC-3 bleeding complications or major cardiac structural complications related to left atrial cannulation.

    Time frame: From enrollment through hospital discharge (up to 30 days post-procedure)

    The primary safety endpoint includes a composite of major vascular, bleeding and cardiac structural complications according to the VARC-3 criteria. For the purpose of this trial the component of the primary safety endpoint will be differentiated between TAVR-related (e.g. associated with the vascular access used for TAVR, valve delivery system or valve implant) and LAVA-ECMO-related (e.g. associated with LAVA-ECMO cannulation including transseptal puncture).

Study contacts

Contact information is provided by the study sponsor or research team.

Gennaro Giustino, MD

CONTACT

[email protected]

9739718858

Pedro Villablanca, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR

Acronym: PROTECT-TAVR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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