NCT07309029Recruiting
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Atlantic Health System
- NCT number
- NCT07309029
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Jan 2026 to the primary completion date, 30 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- \- 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)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Structural Heart Disease Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Valve and Structural Heart Center Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.