Prognostic Factors in NOP-LBBB After TAVI

Not yet recruiting

• Conditions: Transcatheter Aortic Valve Replacement

• Registration Number: NCT05654792
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study Start: 2022-12-10
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalisation for heart failure or all-cause mortality	At one-year after transcatheter aortic valve implantation	Hospitalisation for heart failure or all-cause mortality

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	At one-year after transcatheter aortic valve implantation	All-cause mortality
Hospitalisation for heart failure	At one-year after transcatheter aortic valve implantation	Hospitalisation for heart failure