Severe Aortic StenosisPROTECT-TAVRNCT07309029
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
An observational study of Severe Aortic Stenosis and Cardiogenic Shock, run by Atlantic Health System at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO
- What is being tested?
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2026to 30 Jun 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 21Show fewer
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pedro Villablanca, MD contact
United States2 sites, 2 recruiting
- Recruiting
Center for Structural Heart Disease Henry Ford Hospital
Detroit, Michigan, 48202
Pedro Villablanca, MD, (313) 916-2600, pvillab1@hfhs.org
- Recruiting
Valve and Structural Heart Center Morristown Medical Center
Morristown, New Jersey, 07960
Gennaro Giustino, MD, 9739718858, gennaro.giustino@atlantichealth.org
About this study
Official title: 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:
- Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?
- 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.
Read more
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
- Conditions
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation
- Being tested
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Keywords
- severe aortic stenosis, cardiogenic shock, TAVR
- Medical subject headings
- Aortic Valve Stenosis, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
Measured: 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.
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).
Measured: From enrollment through hospital discharge (up to 30 days post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Giustino, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309029
- Sponsor's protocol ID
- 2337824
- Acronym
- PROTECT-TAVR
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33888385Golzarian 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.
PubMed 37890858Giustino 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.
PubMed 38629421Fraccaro 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.
PubMed 37624587Villablanca 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.
PubMed 36265949Sabharwal 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.
PubMed 37913501Lemor 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.
PubMed 37288119Lama 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.
PubMed 37140503Fang 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.
PubMed 39484326Chiang 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.
PubMed 35257102Chiang 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.
PubMed 35981853Nair 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.
PubMed 39429239Burkhoff 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.
PubMed 26670067Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
PubMed 24171518
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR
- ClinicalTrials.gov ID
- NCT07309029
- Acronym / sponsor ID
- PROTECT-TAVR / 2337824
- Conditions
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation
- Keywords
- severe aortic stenosis, cardiogenic shock, TAVR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?
- 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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (21 listed)
- 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
- Anatomic criteria
Key exclusion criteria (11 listed)
- Age <18 or pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 33888385VARC-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.
- Background: PubMed 37890858Golzarian 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.
- Background: PubMed 38629421Giustino 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.
- Background: PubMed 37624587Fraccaro 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.
- Background: PubMed 36265949Villablanca 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.
- Background: PubMed 37913501Sabharwal 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.
- Background: PubMed 37288119Lemor 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.
- Background: PubMed 37140503Lama 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.
- Background: PubMed 39484326Fang 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.
- Background: PubMed 35257102Chiang 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.
- Background: PubMed 35981853Chiang 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.
- Background: PubMed 39429239Nair 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Villablanca, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis and Cardiogenic Shock, run by Atlantic Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gennaro Giustino, MD (9739718858, Gennaro.Giustino@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309029, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.