Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: RAP TAVI

• Registration Number: NCT05278585
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,

2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,

3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

Detailed Description

The persistent growth in transcatheter aortic valve implantation (TAVI) calls for optimized early discharge programs to handle the increasing patient load. While access site bleeding and stroke rate have decreased with improved technologies and operators' experience, acquired conduction abnormalities necessitating prolonged rhythm-monitoring and permanent pacemaker (PPM) implantation have remained largely unchanged, and even up to 39.9% for some TAVI platforms. Prompt identification of patients necessitating PPM implantation leads to optimal patient care and use of resources. Conversely, prompt identification of patients with low -to no- risk for PPM post TAVI shortens their hospitalization and facilitates early and safe discharge.

Several baseline characteristics such as age, preexistent right bundle branch block (RBBB) and the use of self-expanding valves are associated with post-TAVI PPM implantation, but more practical and clinically more relevant parameters are needed with high negative and positive predictive values that could support clinical decision-making.

En passant rapid atrial pacing (RAP) immediately following TAVI has recently been reported to be a valuable tool in PPM risk stratification. The absence of Wenckebach phenomena post implantation at RAP up to 120/' has a negative predictive value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data). This technique improves our clinical assessment and identification of low-risk patients for PPM suitable for safe early discharge, as well as high-risk patients requiring further rhythm monitoring and eventual PPM implantation.

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,

2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,

3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-14
• Study Start: 2022-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients in sinus rhythm with TAVI

Exclusion Criteria

• Patients in atrial fibrillation at the time of the implantation
• Patients with pre-existent pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RAP TAVI group	RAP TAVI	All patients in sinus rhythm with TAVI

Primary Outcome Measures

Name	Time	Method
Permanent pacemaker implantation	1 month after TAVI
Positive and negative predictive value of RAP for PPM implantation post TAVI	1 month after TAVI
New conduction abnormalities	within 1 week after TAVI

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	1 month after TAVI
Stroke	1 month after TAVI
Duration of hospitalization	1 month after TAVI
Echocardiographic changes	1 month after TAVI
Major vascular bleeding	1 month after TAVI
New pericardial effusion	1 month after TAVI

Trial Locations

Locations (12)

AZ Sint Jan; 🇧🇪 Brugge, Belgium

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

UZ Brussel; 🇧🇪 Jette, Belgium

Citadelle Hospital; 🇧🇪 Liège, Belgium

Clinique Saint-Luc Bouge; 🇧🇪 Namur, Belgium

Algemeen Stedelijk Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium

CHU Charleroi-Chimay; 🇧🇪 Charleroi, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium