Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI

Aortic Valve Stenosis Clinical Trial

— PACE-TAVI  

Official title:

Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278585
• Other study ID #: version 1 21/02/2022
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: AZ Sint-Jan AV
• Contact: Ian Buysschaert, MD, PhD
• Phone: +32050452670
• Email: ian.buysschaert[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• RAP TAVI
All patients undergoing TAVI with no pre-existing pacemaker and in sinus rhythm at the time of the procedure will receive RAP by placing the temporary wire in the right atrium

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis Aalst	Aalst
Belgium	OLV Aalst	Aalst
Belgium	ZNA Middelheim	Antwerp
Belgium	AZ Sint Jan	Brugge
Belgium	CHU Charleroi-Chimay	Charleroi
Belgium	Grand Hôpital de Charleroi	Charleroi
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	UZ Brussel	Jette
Belgium	UZ Leuven	Leuven
Belgium	Citadelle Hospital	Liège
Belgium	Clinique Saint-Luc Bouge	Namur
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative predictive value of RAP for PPM implantation post TAVI		1 month after TAVI
Primary	Permanent pacemaker implantation		1 month after TAVI
Primary	New conduction abnormalities		within 1 week after TAVI
Secondary	Duration of hospitalization		1 month after TAVI
Secondary	Echocardiographic changes		1 month after TAVI
Secondary	Stroke		1 month after TAVI
Secondary	Major vascular bleeding		1 month after TAVI
Secondary	New pericardial effusion		1 month after TAVI
Secondary	All-cause mortality		1 month after TAVI