Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587672
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Factors Affecting Selection of Leadless Pacemaker in Patients with Atrioventricular Block and Atrioventricular Synchronous Pacing Status with a Micra AV a Multicenter Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter prospective observational study the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker
Detailed Description:
Traditional pacemakers consist of a pulse generator and leads Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakersLeadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patientsThe initial design of leadless pacemakers focused on single-chamber right ventricularsensing and pacingHowever patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony Furthermore a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failureRecent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometerThis study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV 2 It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest while analyzing factors that influence the AV synchronyFor all screened patients a questionnaire is required to be finished with data including age gender occupation educational level clinical history comorbidities previous infections history of implanted electronic devices economic status and medical insurance conditions At same time all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device optionAn ambulatory electrocardiogram will be performed at 3 months 6 months and 1 year follow-up after device implantation Data regarding the proportion of atrioventricular Research Protocol Template Observational Study_V10_20231004 710 synchrony atrial sensing atrial contraction mechanical wave A4 threshold ventricular pacing threshold sensing and impedance will be tested and collected Postoperative exercise related symptoms and adverse events will be routinely tracked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None