Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05883631
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-05-22
Brief Title:
RESOLVE-AF Clinical Evaluation of the Ablacath Mapping Catheter and Ablamap System Utilizing Electrographic Flow EGF Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy
Sponsor:
Ablacon Inc
Organization:
Cortex
Study Overview
Official Title:
Prospective Single Arm Multi-center Clinical Evaluation of the Ablacath Mapping Catheter and Ablamap System Utilizing Electrographic Flow EGF Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
RESOLVE-AF
Brief Summary:
Demonstrate the safety and effectiveness of the Ablacath Mapping Catheter and Ablamap System in patients with all types of atrial fibrillation AF including paroxysmal or persistent or long-standing persistent undergoing and De Novo or Redo procedures
Phenotype patients and demonstrate the prognostication power of Electrographic Flow EGF maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation
Phenotype patients and demonstrate the prognostication power of Electrographic Flow EGF maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation
Detailed Description:
Subjects with all types of AF who are candidates for catheter ablation of their AF The study will enroll up to 400 subjects in 25 centers globally
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?:
True
Is an FDA AA801 Violation?:
None