AzTrials
AzTrials

Cardiogenic ShockIMMERGENCT06690567

Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention

An observational study of Cardiogenic Shock and PCI Patients, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Impella implantation
Type of treatment
Medical device
How many people
700 participants
Where
1 siteItaly
Study dates
10 Oct 2024to 10 Dec 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Paitents with cardiogenic shock or CHIP-PCI who underwent Impella device implantation

Who may be able to join

  • Males or females ≥ 18 years-old with CS or CHIPs
  • Impella® device implanted (CP, 5, 5.5)

Who cannot join

  • Age < 18 years
  • No Impella implanted

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • AOU Città della Salute e della Scienza di Torino

    Torino, Italy

Other trials in Italy

About this study

The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.

Being tested
Impella implantation
Keywords
IMPELLA, CARDIOGENIC SHOCK, COMPLEX PCI
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impella implantationDevice

    To implante Impella

Study groups in NCT06690567
Study groupRoleWhat they receive
Patient with cardiogenic shock or patients undergoing complex PCI, with Impella implantationImpella implantation as only intervention needed
Receives: Device: Impella implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. long-term overall mortality

    Measured: 12 months

Secondary outcomes (5)

  1. 30-day overall and cardiovascular mortality

    Measured: 30 day

  2. Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT)

    Measured: 12 months

  3. Rate of bleedings according to the BARC classification

    Measured: 12 months

  4. Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition)

    Measured: 12 months

  5. Rate of neurological events (stroke and TIA)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start10 Oct 2024
  3. Primary completion10 Dec 2024 (estimated)
  4. Study completion10 Dec 2024 (estimated)

Resources

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
700 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690567
Sponsor's protocol ID
IMMMERGE
Acronym
IMMERGE
Status last verified
Dec 2023
First submitted
4 Nov 2024
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • O'Neill WW, Anderson M, Burkhoff D, Grines CL, Kapur NK, Lansky AJ, Mannino S, McCabe JM, Alaswad K, Daggubati R, Wohns D, Meraj PM, Pinto DS, Popma JJ, Moses JW, Schreiber TL, Magnus Ohman E. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J. 2022 Jun;248:139-149. doi: 10.1016/j.ahj.2022.02.006. Epub 2022 Feb 19.

    PubMed 35192839

  • O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30.

    PubMed 22935569

  • Chieffo A, Ancona MB, Burzotta F, Pazzanese V, Briguori C, Trani C, Piva T, De Marco F, Di Biasi M, Pagnotta P, Casu G, Giustino G, Montorfano M, Pappalardo F, Tarantini G; Collaborators. Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry. EuroIntervention. 2020 Feb 7;15(15):e1343-e1350. doi: 10.4244/EIJ-D-19-00428.

    PubMed 31422925

  • Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.

    PubMed 32040163

  • Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.

    PubMed 30586755

  • Geller BJ, Sinha SS, Kapur NK, Bakitas M, Balsam LB, Chikwe J, Klein DG, Kochar A, Masri SC, Sims DB, Wong GC, Katz JN, van Diepen S; American Heart Association Acute Cardiac Care and General Cardiology Committee of the Council on Clinical Cardiology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Cardiovascular Surgery and Anesthesia. Escalating and De-escalating Temporary Mechanical Circulatory Support in Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 9;146(6):e50-e68. doi: 10.1161/CIR.0000000000001076. Epub 2022 Jul 7.

    PubMed 35862152

  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

    PubMed 37622654

  • Potapov EV, Antonides C, Crespo-Leiro MG, Combes A, Farber G, Hannan MM, Kukucka M, de Jonge N, Loforte A, Lund LH, Mohacsi P, Morshuis M, Netuka I, Ozbaran M, Pappalardo F, Scandroglio AM, Schweiger M, Tsui S, Zimpfer D, Gustafsson F. 2019 EACTS Expert Consensus on long-term mechanical circulatory support. Eur J Cardiothorac Surg. 2019 Aug 1;56(2):230-270. doi: 10.1093/ejcts/ezz098.

    PubMed 31100109

  • Lauten A, Engstrom AE, Jung C, Empen K, Erne P, Cook S, Windecker S, Bergmann MW, Klingenberg R, Luscher TF, Haude M, Rulands D, Butter C, Ullman B, Hellgren L, Modena MG, Pedrazzini G, Henriques JP, Figulla HR, Ferrari M. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013 Jan;6(1):23-30. doi: 10.1161/CIRCHEARTFAILURE.112.967224. Epub 2012 Dec 4.

    PubMed 23212552

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock and PCI Patients, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

long-term overall mortality (time frame: 12 months). 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 NCT06690567, which also lists 9 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 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in