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

• Sponsor: AZ Sint-Jan AV (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05278585
• Collaborator: (none)
• Enrollment: 500
• Anticipated Duration (Months): 25

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	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value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data).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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Positive and negative predictive value of RAP for PPM implantation post TAVI [1 week after TAVI]

2. Permanent pacemaker implantation [within few days after TAVI]

3. New conduction abnormalities [within 1 week after TAVI]

Secondary Outcome Measures

1. Duration of hospitalization [1 year after TAVI]

2. Echocardiographic changes [1 year after TAVI]

3. Stroke [1 year after TAVI]

4. Major vascular bleeding [1 year after TAVI]

5. New peridcardial effusion [1 year after TAVI]

6. All-cause mortality [1 year after TAVI]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AZ Sint-Jan AV

Investigators

• Principal Investigator: Ian Buysschaert, MD, PhD, AZ Sint Jan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ian Buysschaert, Principal Investigator, AZ Sint-Jan AV
• ClinicalTrials.gov Identifier: NCT05278585
• Other Study ID Numbers: version 1 21/02/2022
• First Posted: Mar 14, 2022
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Mar 14, 2022