STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI

NCT03338582 | Unknown DMC

• 1 other identifier: ARCAlpes
• Study Type: observational
• Target: 275
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.

Conditions

Pacemaker Implantation; TAVI

Keywords

Pacemaker; Conduction disturbance; TAVI

Outcome Measures

Primary Outcomes (1)

• To look for one or several high level A-V block episodes beyond seven days after a TAVI procedure, by the analysis of the EKG and of the pacemaker memories during the follow-up visits

  High level A-V Block in patients after TAVI procedure is defined: * Either by the analysis of the pacemaker memories during the follow-up visits showing the switches from AAI Safe-R to DDD mode after one or more of these three reasons: * a succession of at least 2 consecutive blocked P waves * more than 3 blocked P waves among 12 consecutive cycles * ventricular pause for over 2 seconds with at least one blocked P wave * Either by the presence of a high level AVB on the EKG during the follow-up visit (pacemaker temporally set to DDI 30 bpm mode) We classify as transitional AVB (D7 persistent, non-persistent beyond 1 month), and permanent AVB (persistent beyond 1 month).

  Until the completion of the study (first follow-up visit 1 to 3 months after TAVI, last follow-up visit 1 year after TAVI)

Secondary Outcomes (1)

• To study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure.

  An average of 8 days (from the day before the TAVI procedure to 7 days after TAVI)

Eligibility Criteria

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

Study Population

275 patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

You may qualify if:

• All patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

You may not qualify if:

• Patients with life expectancy at hospital discharge estimated as less than 1 year
• TAVI procedure failure
• Patients refusing to be involved in the study
• Patients implanted with a PM of a brand different than Sorin® during the hospital phase or implanted Sorin® PM but not set in a AAI or AAI SafeR SafeR-R mode
• Patients with PM implant before TAVI
• Permanent AF at the implantation time
• Patients with Single or Triple chamber PM

Sponsors & Collaborators

• Association de Recherche en Cardiologie des Alpes: lead
• LivaNova: collaborator

Related Publications (1)

• Irles D, Salerno F, Cassagneau R, Eschalier R, Maupain C, Dupuis JM, Mansourati J, Guedon L, Marijon E, Frey P; Other members of the STIMulation cardiaque post-TAVI (STIM-TAVI) study. Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated. J Cardiovasc Electrophysiol. 2021 May;32(5):1376-1384. doi: 10.1111/jce.14970. Epub 2021 Mar 4.

  PMID: 33625762 DERIVED

Study Officials

• Didier IRLES, Dr

  Association de Recherche en Cardiologie des Alpes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 9, 2017
• Study Start: November 1, 2015
• Primary Completion: January 19, 2018
• Study Completion: April 19, 2018
• Last Updated: November 9, 2017

Record last verified: 2017-11