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Aortic Valve StenosisTAVIKODNCT07626710

Impact of Trans-catheter Aortic Valve Implantation on Renal Function

An observational study of Aortic Valve Stenosis and Chronic Kidney Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trans-catheter aortic valve implantation (TAVI)
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteItaly
Study dates
30 Aug 2024to 30 Aug 2033
How long will I take part?
5 Years
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.

Who may be able to join

  • Age >18 years with a life expectancy >1 year;
  • Patient candidate for percutaneous aortic valve implantation after formal indication of our "Heart Team".
  • Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months.
  • Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days.
  • Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date).

Who cannot join

  • Female with childbearing potential or lactating;
  • Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2);
  • Candidate for dialysis treatment;
  • Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year;
  • Absent or incomplete renal function assessment after each contrast-based procedure;
  • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Enrico Romagnoli, MD, PhD contact

+390630154187

enromagnoli@gmail.com

Benedetta Brancadoro contact

+390630154187

benedetta.brancadoro@unicatt.it

Italy1 site, 1 recruiting

  • Enrico Romagnoli

    Roma, RM, 00168

    Enrico Romagnoli, MD, PhD, +393291424342, enrico.romagnoli@policlinicogemelli.it

    Benedetta Brancadoro, +390630156622, benedetta.brancadoro@unicatt.it

    Recruiting

Other trials in Italy

About this study

Official title: Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry

Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown.

This registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution

Read the detailed description

All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution after the introduction of a standardized approach (2017 - TAVI lite technique) will be eligible for the study. To be enrolled in this registry, patients need to have performed both diagnostic preliminary exams (coronary angiography, percutaneous coronary intervention, or CT) and TAVI procedure in our hospital within maximal time lapse of two months. A complete renal function assessment after each contrast-based procedure (i.e. at least three measurements) is also an essential pre-requisite for enrolment.

Study design: ambispective registry. Estimated population size: 340 for the retrospective phase (based on annual TAVI procedure rate of ~150); 760 for the prospective phase (based on annual TAVI procedure rate of ~200) The incidence of contrast medium-induced acute kidney injury according to Kidney Disease Improving Global Outcomes (KDIGO) classification before and after the TAVI procedure will be the primary end-point of the study. The Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI will be the co-primary end-point.

Being tested
Trans-catheter aortic valve implantation (TAVI)
Keywords
Trans-catheter aortic valve implantation, Contrast-induced acute renal injury, Kidney failure, Observational registry
Medical subject headings
Aortic Valve Stenosis, Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

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

  • Trans-catheter aortic valve implantation (TAVI)Procedure or surgery

    Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis

Study groups in NCT07626710
Study groupRoleWhat they receive
TAVI patientsAll patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.
Receives: Procedure: Trans-catheter aortic valve implantation (TAVI)

What is being measured

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

  1. Rate of Contrast-induced acute kidney injuy

    contrast medium induced acute kidney injury according to KDIGO classification

    Measured: In-hospital (up to day 5)

  2. Rate of 1-year mortality

    Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.

    Measured: 1-year follow-up

Secondary outcomes (3)

  1. Rate of 30-day procedural safety

    Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.

    Measured: 1-month follow-up

  2. Days of hospitalization

    Days of hospitalization following TAVI procedure

    Measured: In hospital (up to day 30)

  3. Rate of 5-year major cardiovascular event

    Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization

    Measured: 5-year follow-up

Timeline

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

  1. First posted4 Jun 2026
  2. Study start30 Aug 2024
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion30 Aug 2033 (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
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07626710
Sponsor's protocol ID
3940
Acronym
TAVIKOD
Status last verified
May 2026
First submitted
9 Mar 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie published results will be shared on reasonable request to the principal investigator.

Publications

  • Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

    PubMed 30883053

  • Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

    PubMed 30883058

  • Thongprayoon C, Cheungpasitporn W, Mao MA, Srivali N, Kittanamongkolchai W, Harrison AM, Greason KL, Kashani KB. Persistent acute kidney injury following transcatheter aortic valve replacement. J Card Surg. 2017 Sep;32(9):550-555. doi: 10.1111/jocs.13200. Epub 2017 Aug 22.

    PubMed 28833503

  • Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.

    PubMed 17331245

  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

    PubMed 15312219

  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PubMed 22890468

  • Burzotta F, Aurigemma C, Romagnoli E, Shoeib O, Russo G, Zambrano A, Verdirosi D, Leone AM, Bruno P, Trani C. A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020 Aug;96(2):459-470. doi: 10.1002/ccd.28697. Epub 2020 Jan 11.

    PubMed 31925991

  • De Silva K, Morton G, Sicard P, Chong E, Indermuehle A, Clapp B, Thomas M, Redwood S, Perera D. Prognostic utility of BCIS myocardial jeopardy score for classification of coronary disease burden and completeness of revascularization. Am J Cardiol. 2013 Jan 15;111(2):172-7. doi: 10.1016/j.amjcard.2012.09.012. Epub 2012 Oct 24.

    PubMed 23102883

  • Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012 Oct 9;60(15):1438-54. doi: 10.1016/j.jacc.2012.09.001.

    PubMed 23036636

  • Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.

    PubMed 15882252

  • Faillace BLR, Ribeiro HB, Campos CM, Truffa AAM, Bernardi FL, Oliveira MDP, Mariani J Jr, Marchini JF, Tarasoutchi F, Lemos PA. Potential of transcatheter aortic valve replacement to improve post-procedure renal function. Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):507-511. doi: 10.1016/j.carrev.2017.03.031. Epub 2017 Apr 2.

    PubMed 29054156

  • Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Thygesen K, Alpert JS, White HD; Biomarker Subcommittee; Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee; Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee; Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee; Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee; Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee; Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee; Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee; Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee; Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG); Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers; Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5. No abstract available.

    PubMed 22958960

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis and Chronic Kidney Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 5 inclusion and 6 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 4 Jun 2026. 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?

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 Enrico Romagnoli, MD, PhD (+390630154187, enromagnoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Contrast-induced acute kidney injuy (time frame: In-hospital (up to day 5)). The study lists 2 primary outcomes in all. 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 NCT07626710, which also lists 12 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 4 Jun 2026.

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