Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
PACE-TAVI
1 other identifier
observational
500
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedNovember 29, 2023
November 1, 2023
1.8 years
March 4, 2022
November 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Positive and negative predictive value of RAP for PPM implantation post TAVI
1 month after TAVI
Permanent pacemaker implantation
1 month after TAVI
New conduction abnormalities
within 1 week after TAVI
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
RAP TAVI group
All patients in sinus rhythm with TAVI
Interventions
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
Eligibility Criteria
500 patients in sinus rhythm undergoing TAVI
You may qualify if:
- All patients in sinus rhythm with TAVI
You may not qualify if:
- Patients in atrial fibrillation at the time of the implantation
- Patients with pre-existent pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
Study Sites (12)
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
OLV Aalst
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
AZ Sint Jan
Bruges, 8000, 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, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Buysschaert, MD, PhD
AZ Sint Jan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 14, 2022
Study Start
September 1, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
November 29, 2023
Record last verified: 2023-11