Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322836
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-21
First Post:
2024-02-27
Brief Title:
A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home
Sponsor:
RAV Brabant MWN
Organization:
RAV Brabant MWN
Study Overview
Official Title:
Electra-1 Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers A Feasibility Study in Dutch Emergency Medical Service
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Electra-1
Brief Summary:
The goal of this pilot non-controlled non-randomised single centre prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients
The main questions it aims to answer are
Primary objective
In this prospective intervention feasibility study in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm of study patients with a recurrence of AF in whom a home cardioversion is performed ie to whom at least one DC shock was administered while the patient was under sedation
Feasibility endpoints are a evaluation of enrolment of participants b evaluation and refinement of data and outcome collection procedures c evaluation of logistics d evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention and e preliminary evaluation of participant responses to the intervention
Secondary objectives
Safety endpoint
Complications immediately during and one hour after cardioversion eg arrhythmias changes in the electrocardiogram hypotension related to sedation andor vasodilation or skin irritation
A composite of major adverse cardiovascular and cerebrovascular events MACCE occurring within 24 hours MACCE occurring during 6 weeks follow-up any hospitalisation and all-cause mortality during 6 weeks follow-up number of patients in sinus rhythm at 1 hour in the post-shock observation period idem at the end of 6 weeks follow-up inventory of all interventions in the study related to cost-of-care
The main questions it aims to answer are
Primary objective
In this prospective intervention feasibility study in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm of study patients with a recurrence of AF in whom a home cardioversion is performed ie to whom at least one DC shock was administered while the patient was under sedation
Feasibility endpoints are a evaluation of enrolment of participants b evaluation and refinement of data and outcome collection procedures c evaluation of logistics d evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention and e preliminary evaluation of participant responses to the intervention
Secondary objectives
Safety endpoint
Complications immediately during and one hour after cardioversion eg arrhythmias changes in the electrocardiogram hypotension related to sedation andor vasodilation or skin irritation
A composite of major adverse cardiovascular and cerebrovascular events MACCE occurring within 24 hours MACCE occurring during 6 weeks follow-up any hospitalisation and all-cause mortality during 6 weeks follow-up number of patients in sinus rhythm at 1 hour in the post-shock observation period idem at the end of 6 weeks follow-up inventory of all interventions in the study related to cost-of-care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None