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Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRT Pacing | Experimental | SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device | Device | Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of test system (MAX-SRS) to record AF | Record 1 run of AF = 60 seconds, categorical variable (Yes/No) | 60 seconds |
| Mean SRT pacing duration per SRT pacing attempt | Record duration (min:sec) of each SRT pacing attempt | min:sec/attempt |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SRT pacing duration to convert AF | Record duration (min:sec) of SRT pacing and organization of clinical rhythm (conversion to arrhythmia other than AF) or AF termination. | Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications related to acute SRT pacing protocol | Assessed post-procedure through hospital discharge (~7 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Khabeishvili, MD | Contact | +995 599 502 255 | georgekhabeishvili@icloud.com | |
| Elene Khabeishvili, MD | Contact | +995 555 737 300 | EleneKhabeishvili@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| George Khabeishvili, MD | Tbilisi Heart and Vascular Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart and Vascular Clinic | Recruiting | Tbilisi | Georgia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |