Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-28 @ 1:51 PM
Study NCT ID:
NCT05461612
Status:
UNKNOWN
Last Update Posted:
2022-07-18
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Sponsor:
Maxwell Biomedical
Organization:
Study Overview
Official Title:
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
SR-TheAF
Brief Summary:
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
Detailed Description:
This is an acute study to test the ability of a custom external device (MAX-SRS) to sense atrial rhythms, determine when AF is present and deliver spatial resynchronization therapy (SRT) to terminate AF.
Patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. The catheters will be connected to the MAX-SRS. If AF is not present, standard pacing measures will be used to induce AF. Once \> 1 minute of AF is recorded, the MAX-SRS will be activated to sense the rhythm and deliver SRT pacing to terminate the AF. Up to five SRT deliveries using the same or different SRT algorithms will be attempted. After the first successful termination of AF or after five SRT attempts the study is complete for each patient. Diagnostic catheters will be removed after the conclusion of the SRT pacing study.
Patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. The catheters will be connected to the MAX-SRS. If AF is not present, standard pacing measures will be used to induce AF. Once \> 1 minute of AF is recorded, the MAX-SRS will be activated to sense the rhythm and deliver SRT pacing to terminate the AF. Up to five SRT deliveries using the same or different SRT algorithms will be attempted. After the first successful termination of AF or after five SRT attempts the study is complete for each patient. Diagnostic catheters will be removed after the conclusion of the SRT pacing study.
Study Oversight
Has Oversight DMC:
False
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?: