Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335082
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-11
First Post:
2024-03-21
Brief Title:
A Registry Based Collaborative to Measure Efficiency Effectiveness and Safety of Farapulse PFA Technology for AF
Sponsor:
Heart Rhythm Clinical and Research Solutions LLC
Organization:
Heart Rhythm Clinical and Research Solutions LLC
Study Overview
Official Title:
A Registry Based Collaborative to Measure Efficiency Effectiveness and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
DISRUPT-AF
Brief Summary:
The DISRUPT-AF Registry is an observational prospective multi-center non-randomized real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation AF
Detailed Description:
The DISRUPT-AF Registry is an observational prospective multi-center non-randomized real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation AF All types of AF including paroxysmal persistent and long standing persistent may be included
The registry has three cohorts 1 Acute Arm 2 Symptomatic Monitoring Only Arm and 3 Full Monitoring Arm In the Acute Arm patient assessments will occur at pre- procedure and procedure visits In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm patient assessments will occur at pre- procedure procedure 3 months and 1 year post ablation Additionally the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation
Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care Sites can only participate in one arm
The primary purpose of the registry is to assess clinical outcomes including procedural efficiency safety and long-term effectiveness of pulsed field ablation PFA in the treatment of patients with AF Also to assess the effect of PFA technology implementation on practice patterns operational workflow and operator experience
The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship
The registry has three cohorts 1 Acute Arm 2 Symptomatic Monitoring Only Arm and 3 Full Monitoring Arm In the Acute Arm patient assessments will occur at pre- procedure and procedure visits In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm patient assessments will occur at pre- procedure procedure 3 months and 1 year post ablation Additionally the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation
Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care Sites can only participate in one arm
The primary purpose of the registry is to assess clinical outcomes including procedural efficiency safety and long-term effectiveness of pulsed field ablation PFA in the treatment of patients with AF Also to assess the effect of PFA technology implementation on practice patterns operational workflow and operator experience
The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None