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Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05278585
Acronym
PACE-TAVI
Enrollment
500
Registered
2022-03-14
Start date
2022-09-01
Completion date
2024-06-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

PROCEDURERAP 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

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Positive and negative predictive value of RAP for PPM implantation post TAVI1 month after TAVI
Permanent pacemaker implantation1 month after TAVI
New conduction abnormalitieswithin 1 week after TAVI

Secondary

MeasureTime frame
Major vascular bleeding1 month after TAVI
Duration of hospitalization1 month after TAVI
All-cause mortality1 month after TAVI
New pericardial effusion1 month after TAVI
Echocardiographic changes1 month after TAVI
Stroke1 month after TAVI

Countries

Belgium

Contacts

Primary ContactIan Buysschaert, MD, PhD
ian.buysschaert@azsintjan.be+32050452670
Backup ContactEmma Christiaen, Msc
Emma.Christiaen@azsintjan.be+32050453293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026