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Status unknownNCT05654792ProgNOP-LBBBUpdated Dec 16, 2022

Prognostic Factors in NOP-LBBB After TAVI

An observational study in Transcatheter Aortic Valve Replacement, sponsored by Central Hospital, Nancy, France. Status unknown. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
230
Sex
All
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Study summary

The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI). The main question it aims to answer is:

Are there any factors influencing heart failure or death risk during the year following TAVI in patients with NOP-LBBB ? Participants will have data collection about TAVI procedure and clinical evolution during a one-year follow-up.

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Conditions studied

  • Transcatheter Aortic Valve Replacement

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Keywords

  • transcatheter aortic valve implantation, aortic stenosis, permanent pacemaker, left bundle branch block, heart failure, cardiac dyssynchrony
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In context

Bundle-Branch Block

91 studies on the registry are indexed under Bundle-Branch Block; 29 are open to participants now.

This study's planned enrollment of 230 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with transcatheter aortic valve implantation in University Hospital of Nancy between 2009 and 31/12/2021, and with left bundle branch block following transcatheter aortic valve implantation and persistent during hospitalisation

Inclusion criteria

  • New-onset persistent left bundle branch block after transcatheter aortic valve implantation

Exclusion criteria

Exclusion Criteria:

  • Pre-existing left bundle branch block
  • Pre-existing right bundle branch block
  • Pre-existing permanent pacemaker
  • Immediate procedural mortality (death ≤72 h post-procedure)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
230 participants (estimated)
Patient registry
No

Groups and cohorts

  • NOP-LBBB

    Patients with new-onset persistent left bundle branch block after transcatheter aortic valve implantation

    Device: Transcatheter aortic valve implantation

Interventions

  • DeviceTranscatheter aortic valve implantation

    Transcatheter aortic valve implantation in cases of severe aortic stenosis

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What researchers measure

Primary outcomes

  1. Hospitalisation for heart failure or all-cause mortality

    Hospitalisation for heart failure or all-cause mortality

    Time frame: At one-year after transcatheter aortic valve implantation

Secondary outcomes

  1. Hospitalisation for heart failure

    Hospitalisation for heart failure

    Time frame: At one-year after transcatheter aortic valve implantation

  2. All-cause mortality

    All-cause mortality

    Time frame: At one-year after transcatheter aortic valve implantation

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Nagaraja V, Raval J, Eslick GD, Ong AT. Transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis of randomised and non-randomised trials. Open Heart. 2014 Aug 12;1(1):e000013. doi: 10.1136/openhrt-2013-000013. eCollection 2014. PubMed 25332780 ↗
  • Hannan EL, Samadashvili Z, Stamato NJ, Lahey SJ, Wechsler A, Jordan D, Sundt TM 3rd, Gold JP, Ruiz CE, Ashraf MH, Smith CR. Utilization and 1-Year Mortality for Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement in New York Patients With Aortic Stenosis: 2011 to 2012. JACC Cardiovasc Interv. 2016 Mar 28;9(6):578-85. doi: 10.1016/j.jcin.2015.12.022. PubMed 27013157 ↗
  • Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5. PubMed 21639811 ↗
  • Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available. PubMed 28886619 ↗
  • Barbanti M, Gulino S, Costa G, Tamburino C. Pathophysiology, incidence and predictors of conduction disturbances during Transcatheter Aortic Valve Implantation. Expert Rev Med Devices. 2017 Feb;14(2):135-147. doi: 10.1080/17434440.2017.1282819. Epub 2017 Jan 21. PubMed 28092726 ↗
  • Urena M, Webb JG, Cheema A, Serra V, Toggweiler S, Barbanti M, Cheung A, Ye J, Dumont E, DeLarochelliere R, Doyle D, Al Lawati HA, Peterson M, Chisholm R, Igual A, Ribeiro HB, Nombela-Franco L, Philippon F, Garcia Del Blanco B, Rodes-Cabau J. Impact of new-onset persistent left bundle branch block on late clinical outcomes in patients undergoing transcatheter aortic valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv. 2014 Feb;7(2):128-136. doi: 10.1016/j.jcin.2013.08.015. Epub 2014 Jan 15. PubMed 24440024 ↗
  • Houthuizen P, Van Garsse LA, Poels TT, de Jaegere P, van der Boon RM, Swinkels BM, Ten Berg JM, van der Kley F, Schalij MJ, Baan J Jr, Cocchieri R, Brueren GR, van Straten AH, den Heijer P, Bentala M, van Ommen V, Kluin J, Stella PR, Prins MH, Maessen JG, Prinzen FW. Left bundle-branch block induced by transcatheter aortic valve implantation increases risk of death. Circulation. 2012 Aug 7;126(6):720-8. doi: 10.1161/CIRCULATIONAHA.112.101055. Epub 2012 Jul 12. PubMed 22791865 ↗
  • Faroux L, Chen S, Muntane-Carol G, Regueiro A, Philippon F, Sondergaard L, Jorgensen TH, Lopez-Aguilera J, Kodali S, Leon M, Nazif T, Rodes-Cabau J. Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. Eur Heart J. 2020 Aug 1;41(29):2771-2781. doi: 10.1093/eurheartj/ehz924. PubMed 31899484 ↗
  • Regueiro A, Abdul-Jawad Altisent O, Del Trigo M, Campelo-Parada F, Puri R, Urena M, Philippon F, Rodes-Cabau J. Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2016 May;9(5):e003635. doi: 10.1161/CIRCINTERVENTIONS.115.003635. PubMed 27169577 ↗
  • Tsushima T, Main A, Al-Kindi SG, Dallan LAP, Wheat HL, Baeza CR, Pelletier MP, Arruda MS, Mackall JA, Thal SG, Ohno Y, Lee KH, Siqueira DA, Kaneko T, Harloff MT, Costa G, Barbanti M, Attizzani GF. Risk Stratification of New Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2022 Jul 15;175:80-87. doi: 10.1016/j.amjcard.2022.03.053. Epub 2022 May 18. PubMed 35597627 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05654792
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Dec 10, 2022 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
May 1, 2023 (estimated)
Last update
Dec 16, 2022

Study contacts

Mathieu ECHIVARD, PhD
Contact
m.echivard@chru-nancy.fr
+3383157356

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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