Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

NCT06189976 | Recruiting DMC

• 1 other identifier: RAP-TAVI
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.

Conditions

Aortic Valve Disease; Transcatheter Aortic Valve Implantation; TAVI

Keywords

TAVR; TAVI; Rapid atrial pacing; Aortic stenosis

Outcome Measures

Primary Outcomes (1)

• Permanent pacemaker implantation rates

  Rates of permanent pacemaker implantation after TAVI

  30 days

Secondary Outcomes (5)

• Mortality rates

  30 days

• Mortality rates

  6 months

• Permanent pacemaker implantation rates

  6 months

• Mortality rates

  12 months

• Permanent pacemaker implantation rates

  12 months

Study Arms (1)

Rapid atrial pacing

OTHER

Diagnostic test group (single group)

Diagnostic Test: Rapid atrial pacing

Interventions

Rapid atrial pacing DIAGNOSTIC_TEST

Rapid atrial pacing after TAVI

Rapid atrial pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old.
• Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
• Patient has given written consent to participate in the trial.
• Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).
• Patient in sinus rhythm.
• Patients planned for TAVI with utilization of temporary pacemaker electrode placement.

You may not qualify if:

• Ongoing infection, including active endocarditis.
• Implanted permanent pacemaker and/or implantable cardioverter/defibrillator.
• Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.
• Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.
• Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.
• Enrolment in another study that competes or interferes with this study.
• Subject will not be able to comply with the follow-up requirements according to investigators' opinion.
• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Centre Hospitalier Universitaire Saint Pierre: collaborator

Study Sites (2)

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Hippocration Hospital

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (4)

• Knecht S, Schaer B, Reichlin T, Spies F, Madaffari A, Vischer A, Fahrni G, Jeger R, Kaiser C, Osswald S, Sticherling C, Kuhne M. Electrophysiology Testing to Stratify Patients With Left Bundle Branch Block After Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2020 Mar 3;9(5):e014446. doi: 10.1161/JAHA.119.014446. Epub 2020 Feb 22.

  PMID: 32089049 RESULT

• Krishnaswamy A, Sammour Y, Mangieri A, Kadri A, Karrthik A, Banerjee K, Kaur M, Giannini F, Pagliaro B, Ancona M, Pagnesi M, Laricchia A, Weisz G, Lyden M, Bazarbashi N, Gad M, Ahuja K, Mick S, Svensson L, Puri R, Reed G, Rickard J, Colombo A, Kapadia S, Latib A. The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation. JACC Cardiovasc Interv. 2020 May 11;13(9):1046-1054. doi: 10.1016/j.jcin.2020.01.215. Epub 2020 Apr 15.

  PMID: 32305392 RESULT

• Tan BE, Hashem A, Boppana LKT, Mohamed MS, Abbas SF, Faisaluddin M, Thakkar S, Ahmed AK, Hall C, Abtahian F, Rao M, Bhatt DL, Depta JP. Utility of rapid atrial pacing before and after TAVR with balloon-expandable valve in predicting permanent pacemaker implantation. Catheter Cardiovasc Interv. 2023 Nov;102(5):919-928. doi: 10.1002/ccd.30817. Epub 2023 Sep 12.

  PMID: 37698294 RESULT

• Koliastasis L, Doundoulakis I, Tsiachris D, Pannone L, Skalidis I, de Hemptinne Q, Xaplanteris P, Toutouzas K, de Asmundis C. Rapid Atrial Pacing After TAVI for Pacemaker Prediction. Rev Cardiovasc Med. 2025 Aug 15;26(8):39074. doi: 10.31083/RCM39074. eCollection 2025 Aug.

  PMID: 40927105 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Leonidas Koliastasis

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonidas Koliastasis, MD, PhD

CONTACT

+30 6974270752; lkoliastasis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology Fellow

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 5, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); GR (1)