Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
NCT ID: NCT05278585
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-09-01
2024-06-30
Brief Summary
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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
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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value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data).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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RAP TAVI group
All patients in sinus rhythm with TAVI
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with pre-existent pacemaker
18 Years
ALL
No
Sponsors
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AZ Sint-Jan AV
OTHER
Responsible Party
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Ian Buysschaert, MD PhD
Principal Investigator
Principal Investigators
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Ian Buysschaert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AZ Sint Jan
Locations
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Algemeen Stedelijk Ziekenhuis Aalst
Aalst, , Belgium
OLV Aalst
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
AZ Sint Jan
Bruges, , 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
Countries
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Central Contacts
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Facility Contacts
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An Roets
Role: primary
Amandine Jourdan
Role: primary
Lieke Peeters
Role: primary
Ingrid Lemoine
Role: primary
Marina Claes
Role: primary
Soon-Ja Collard
Role: primary
Els Vancayseele
Role: primary
Other Identifiers
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version 1 21/02/2022
Identifier Type: -
Identifier Source: org_study_id