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Transcatheter Aortic Valve ReplacementProgNOP-LBBBNCT05654792

Prognostic Factors in NOP-LBBB After TAVI

An observational study of Transcatheter Aortic Valve Replacement, run by Central Hospital, Nancy, France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Transcatheter Aortic Valve Replacement
What is being tested?
Transcatheter aortic valve implantation
Type of treatment
Medical device
How many people
230 participants
Where
No sites listed yet
Study dates
10 Dec 2022to 1 May 2023
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Mathieu ECHIVARD, PhD contact

+3383157356

m.echivard@chru-nancy.fr

About this study

Official title: Prognostic Factors in New-Onset Persistent Left Bundle Branch Block After Transcathether Aortic Valve Implantation

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.

Being tested
Transcatheter aortic valve implantation
Keywords
transcatheter aortic valve implantation, aortic stenosis, permanent pacemaker, left bundle branch block, heart failure, cardiac dyssynchrony
Medical subject headings
Aortic Valve Stenosis, Bundle-Branch Block, Heart Failure

What participants receive

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

  • Transcatheter aortic valve implantationDevice

    Transcatheter aortic valve implantation in cases of severe aortic stenosis

Study groups in NCT05654792
Study groupRoleWhat they receive
NOP-LBBBPatients with new-onset persistent left bundle branch block after transcatheter aortic valve implantation
Receives: Device: Transcatheter aortic valve implantation

What is being measured

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

  1. Hospitalisation for heart failure or all-cause mortality

    Hospitalisation for heart failure or all-cause mortality

    Measured: At one-year after transcatheter aortic valve implantation

Secondary outcomes (2)

  1. Hospitalisation for heart failure

    Hospitalisation for heart failure

    Measured: At one-year after transcatheter aortic valve implantation

  2. All-cause mortality

    All-cause mortality

    Measured: At one-year after transcatheter aortic valve implantation

Timeline

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

  1. First posted16 Dec 2022
  2. Study start10 Dec 2022 (estimated)
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 May 2023 (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
Retrospective
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654792
Sponsor's protocol ID
2022PI163
Acronym
ProgNOP-LBBB
Status last verified
Dec 2022
First submitted
8 Dec 2022
Last updated
16 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Transcatheter Aortic Valve Replacement, run by Central Hospital, Nancy, France.

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 1 inclusion and 4 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Mathieu ECHIVARD, PhD (+3383157356, m.echivard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalisation for heart failure or all-cause mortality (time frame: At one-year after transcatheter aortic valve implantation). 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 NCT05654792, which also lists 10 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 16 Dec 2022.

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