TAVI Clinical Trial
— STIMTAVIOfficial title:
STIMulation Cardiaque et TAVI : évolution Des Troubles Conductifs Atrio-ventriculaires après TAVI
Verified date | November 2017 |
Source | Association de Recherche en Cardiologie des Alpes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 275 |
Est. completion date | April 19, 2018 |
Est. primary completion date | January 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Association de Recherche en Cardiologie des Alpes | LivaNova |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure. | In accordance with the secondary objective, we will study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure : preexisting conduction disturbances (complete right bundle branch block, left anterior hemiblock, first degree A-V block), high grade AVB during the TAVI procedure, worsening of conduction disturbances during the procedure or within the next hour (appearance of a left bundle branch block, QRS widening beyond 120ms, prolongation of PR beyond 200ms ), lengthening of the HV interval immediately after the procedure TAVI or later (if an electrophysiological study is performed), implantation of a Medtronic® CoreValve prosthesis (compared to an Edwards® Sapien prosthesis), height of the implantation of the valve, oversizing. | An average of 8 days (from the day before the TAVI procedure to 7 days after TAVI) |
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