Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI (PACE-TAVI)

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

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 Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: RAP TAVI

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value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data).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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Ian Buysschaert, MD, PhD; Phone Number: +32050452670; Email: ian.buysschaert@azsintjan.be
• Study Contact Backup: Name: Emma Christiaen, Msc; Phone Number: +32050453293; Email: Emma.Christiaen@azsintjan.be

Study Locations

• Belgium
  • Aalst, Belgium
    • Recruiting
    • OLV Aalst
    • Contact: Steve Aerts; Email: Cardio.studie.aalst@olvz-aalst.be
    • Principal Investigator: Marc Vanderheyden, MD
  • Aalst, Belgium
    • Recruiting
    • Algemeen Stedelijk Ziekenhuis Aalst
    • Principal Investigator: Liesbeth Rosseel, MD
    • Contact: An Roets
  • Antwerp, Belgium
    • Recruiting
    • ZNA Middelheim
    • Contact: Petra Vanextergem; Email: studies.cardio@zna.be
    • Principal Investigator: Benjamin Scott, MD
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint Jan
    • Contact: Ian Buysschaert, MD PhD; Phone Number: +32 50 45 26 70; Email: ian.buysschaert@azsintjan.be
    • Principal Investigator: Ian Buysschaert, MD, PhD
  • Charleroi, Belgium
    • Recruiting
    • Grand Hôpital de Charleroi
    • Contact: Amandine Jourdan
    • Principal Investigator: Frédéric De Vroey, MD
  • Charleroi, Belgium
    • Recruiting
    • CHU Charleroi-Chimay
    • Principal Investigator: Adel Aminian, MD
    • Contact: Asuncion Conde Y Bolado; Email: sncardio@humani.be
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Lieke Peeters
    • Principal Investigator: Bert Ferdinande, MD
  • Jette, Belgium
    • Recruiting
    • UZ Brussel
    • Contact: Ingrid Lemoine
    • Principal Investigator: Bert Vandeloo, MD
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Marina Claes
    • Principal Investigator: Tom Adriaenssens, MD, PhD
  • Liège, Belgium
    • Recruiting
    • Citadelle Hospital
    • Contact: Sophie Jacquet; Email: rc-cardio@citadelle.be
    • Principal Investigator: Charles Pirlet, MD
  • Namur, Belgium
    • Recruiting
    • Clinique Saint-Luc Bouge
    • Contact: Soon-Ja Collard
    • Principal Investigator: François Simon, MD
  • Roeselare, Belgium
    • Recruiting
    • AZ Delta
    • Contact: Els Vancayseele
    • Principal Investigator: Francis Stammen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

500 patients in sinus rhythm undergoing TAVI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RAP TAVI group; All patients in sinus rhythm with TAVI	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Ian Buysschaert, MD, PhD, AZ Sint Jan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: version 1 21/02/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No