Clinical trial NCT05654792: Prognostic Factors in NOP-LBBB After TAVI
Official title: Prognostic Factors in New-Onset Persistent Left Bundle Branch Block After Transcathether Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcatheter Aortic Valve Replacement
Keywords: transcatheter aortic valve implantation, aortic stenosis, permanent pacemaker, left bundle branch block, heart failure, cardiac dyssynchrony
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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)

Primary outcomes:
measure: Hospitalisation for heart failure or all-cause mortality
timeFrame: At one-year after transcatheter aortic valve implantation
Secondary outcomes:
measure: Hospitalisation for heart failure
timeFrame: At one-year after transcatheter aortic valve implantation
measure: All-cause mortality
timeFrame: At one-year after transcatheter aortic valve implantation
Other outcomes:
Locations:
Study officials:
References:
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