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Clinical Trials/NCT07309029
NCT07309029
Recruiting
Not Applicable

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

Atlantic Health System2 sites in 1 country30 target enrollmentStarted: January 1, 2026Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Outcomes

Primary Outcomes

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

  • 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.(From enrollment through hospital discharge (up to 30 days post-procedure))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gennaro Giustino

MD

Atlantic Health System

Study Sites (2)

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