Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2026-01-01
2027-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
OTHER
Interventions
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Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Atlantic Health System
OTHER
Responsible Party
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Gennaro Giustino
MD
Locations
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Center for Structural Heart Disease Henry Ford Hospital
Detroit, Michigan, United States
Valve and Structural Heart Center Morristown Medical Center
Morristown, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Pedro Villablanca, MD
Role: primary
Gennaro Giustino, MD
Role: primary
References
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VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
Golzarian H, Thiel A, Hempfling G, Otto M, Otto T, Shappell E, Racer L, Martz D, Recker-Herman CM, Laird A, Cole WC, Sirak J, Patel SM. Severe aortic insufficiency-induced cardiogenic shock treated with left atrial VA-ECMO and emergent valve-in-valve TAVR. ESC Heart Fail. 2023 Dec;10(6):3718-3724. doi: 10.1002/ehf2.14561. Epub 2023 Oct 27.
Giustino G, O'Neill BP, Wang DD, Frisoli T, Fang JX, Engel-Gonzalez P, Lee J, Fadel R, O'Neill WW, Villablanca PA. Feasibility and safety of transcaval venoarterial extracorporeal membrane oxygenation in severe cardiogenic shock. EuroIntervention. 2024 Apr 15;20(8):e511-e513. doi: 10.4244/EIJ-D-23-01046. No abstract available.
Fraccaro C, Karam N, Mollmann H, Bleiziffer S, Bonaros N, Teles RC, Carrilho Ferreira P, Chieffo A, Czerny M, Donal E, Dudek D, Dumonteil N, Esposito G, Fournier S, Hassager C, Kim WK, Krychtiuk KA, Mehilli J, Pregowski J, Stefanini GG, Ternacle J, Thiele H, Thielmann M, Vincent F, von Bardeleben RS, Tarantini G. Transcatheter interventions for left-sided valvular heart disease complicated by cardiogenic shock: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the Association for Acute Cardiovascular Care (ACVC) and the ESC Working Group on Cardiovascular Surgery. EuroIntervention. 2023 Oct 23;19(8):634-651. doi: 10.4244/EIJ-D-23-00473.
Villablanca PA, Al-Darzi W, Boshara A, Hana A, Basir M, O'Neill B, Frisoli T, Lee J, Wang DD, O'Neill WW. Left Atrial Venoarterial Extracorporeal Membrane Oxygenation for Patients in Cardiogenic Shock and Acute Aortic Regurgitation. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2112-2114. doi: 10.1016/j.jcin.2022.08.015. Epub 2022 Sep 28. No abstract available.
Sabharwal A, Tsiouris A, Slaughter MS, Lemor A, Jeyakumar AKC, Protos A, Hernandez GA. Left Atrial-Veno Arterial Extracorporeal Membrane Oxygenation as a Bridge to Surgery for Endocarditis-Related Acute Severe Aortic Regurgitation. ASAIO J. 2024 Apr 1;70(4):e61-e64. doi: 10.1097/MAT.0000000000002077. Epub 2023 Nov 1.
Lemor A, Basir MB, O'Neill BP, Cowger J, Frisoli T, Lee JC, Wang DD, Alaswad K, O'Neill W, Villablanca PA. Left Atrial-Veno-Arterial Extracorporeal Membrane Oxygenation: Step-By-Step Procedure and Case Example. Struct Heart. 2022 Oct 31;6(6):100117. doi: 10.1016/j.shj.2022.100117. eCollection 2022 Nov.
Lama von Buchwald C, Gonzalez PE, O'Neill B, Wang DD, Frisoli T, O'Neill WW, Villablanca PA. Percutaneous Retrieval of an Aortic Valve Vegetation Causing Severe Regurgitation and Cardiogenic Shock. JACC Cardiovasc Interv. 2023 May 22;16(10):1301-1303. doi: 10.1016/j.jcin.2023.03.027. Epub 2023 May 3. No abstract available.
Fang JX, Giustino G, Apostolou D, Lee JC, Wang DD, Engel Gonzalez P, O'Neill BP, Frisoli TM, O'Neill WW, Villablanca PA. LAVA-ECMO-Supported Dual-Transcatheter Aortic and Mitral Valve-in-Valve Replacement in Cardiogenic Shock. JACC Case Rep. 2024 Oct 2;29(19):102564. doi: 10.1016/j.jaccas.2024.102564. eCollection 2024 Oct 2.
Chiang M, Gonzalez PE, O'Neill BP, Lee J, Frisoli T, Wang DD, O'Neill WW, Villablanca PA. Left Atrial Venoarterial Extracorporeal Membrane Oxygenation for Acute Aortic Regurgitation and Cardiogenic Shock. JACC Case Rep. 2022 Mar 2;4(5):276-279. doi: 10.1016/j.jaccas.2021.12.030. eCollection 2022 Mar 2.
Chiang M, Gonzalez PE, Basir MB, O'Neill BP, Lee J, Frisoli T, Wang DD, O'Neill WW, Villablanca PA. Modified Transcaval Left Atrial Venoarterial Extracorporeal Membrane Oxygenation Without Preplanning Contrast CT: Step-by-Step Guide. JACC Cardiovasc Interv. 2022 Aug 22;15(16):e181-e185. doi: 10.1016/j.jcin.2022.05.033. Epub 2022 Jul 13. No abstract available.
Nair RM, Chawla S, Alkhalaileh F, Abdelghaffar B, Bansal A, Higgins A, Lee R, Rampersad P, Khot UN, Jaber WA, Reed GW, Cremer PC, Menon V. Characteristics and Outcomes of Patients With Valvular Cardiogenic Shock. JACC Adv. 2024 Oct 4;3(11):101303. doi: 10.1016/j.jacadv.2024.101303. eCollection 2024 Nov.
Burkhoff D, Sayer G, Doshi D, Uriel N. Hemodynamics of Mechanical Circulatory Support. J Am Coll Cardiol. 2015 Dec 15;66(23):2663-2674. doi: 10.1016/j.jacc.2015.10.017.
Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
Other Identifiers
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2337824
Identifier Type: -
Identifier Source: org_study_id