Clinical trial NCT05278585: Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
Official title: Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients in sinus rhythm undergoing TAVI

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive and negative predictive value of RAP for PPM implantation post TAVI
timeFrame: 1 month after TAVI
measure: Permanent pacemaker implantation
timeFrame: 1 month after TAVI
measure: New conduction abnormalities
timeFrame: within 1 week after TAVI
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: 1 month after TAVI
measure: Echocardiographic changes
timeFrame: 1 month after TAVI
measure: Stroke
timeFrame: 1 month after TAVI
measure: Major vascular bleeding
timeFrame: 1 month after TAVI
measure: New pericardial effusion
timeFrame: 1 month after TAVI
measure: All-cause mortality
timeFrame: 1 month after TAVI
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Charleroi
country: Belgium
facility: CHU Charleroi-Chimay
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Citadelle Hospital
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
affiliation: AZ Sint Jan
name: Ian Buysschaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: