Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR (PROTECT-TAVR)

December 15, 2025 updated by: Gennaro Giustino, Atlantic Health System

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Center for Structural Heart Disease Henry Ford Hospital
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited from Atlantic Health System hospitals and affiliated centers. Eligible individuals are adult patients diagnosed with severe native aortic stenosis or degenerated bioprosthetic aortic valves who are scheduled for transcatheter aortic valve replacement (TAVR). Patients are identified through institutional clinical practices and referrals, including those admitted to the cardiac care unit with signs of hemodynamic instability or anatomical complexity. Recruitment may include critically ill patients who are sedated or intubated, with consent obtained from legally authorized representatives when necessary.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From enrollment through hospital discharge (up to 30 days post-procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment through hospital discharge (up to 30 days post-procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2337824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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