Prognostic Factors in NOP-LBBB After TAVI (ProgNOP-LBBB)

December 8, 2022 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NOP-LBBB
Patients with new-onset persistent left bundle branch block after transcatheter aortic valve implantation
Device: Transcatheter aortic valve implantation
Transcatheter aortic valve implantation in cases of severe aortic stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalisation for heart failure or all-cause mortality
Time Frame: At one-year after transcatheter aortic valve implantation
Hospitalisation for heart failure or all-cause mortality
At one-year after transcatheter aortic valve implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalisation for heart failure
Time Frame: At one-year after transcatheter aortic valve implantation
Hospitalisation for heart failure
At one-year after transcatheter aortic valve implantation
All-cause mortality
Time Frame: At one-year after transcatheter aortic valve implantation
All-cause mortality
At one-year after transcatheter aortic valve implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 10, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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