Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SR-TheAF  

Official title:

Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461612
• Other study ID #: CLP22-001
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Maxwell Biomedical
• Contact: George Khabeishvili, MD
• Phone: +995 599 502 255
• Email: georgekhabeishvili[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have AF that persists (Persistent AF) for more than 7 days but less than 1 year; OR has required cardioversion for termination of AF in the past 6 months; AND is not due to a reversible cause.

• Be scheduled to undergo open-heart surgery

• Be able to adhere to follow-up requirements

Exclusion Criteria:

• Have active pericarditis or any systemic infection

• Have left atrial thrombus (including left atrial appendage)

• Have had a previous attempt to ablate atrial fibrillation

• Scheduled for left atrial exclusion or excision

• Have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion

• Have NYHA Class IV heart failure

• Have long-standing persistent or permanent AF

• Long-standing persistent AF is defined as AF that persists for greater than 1 year

• Permanent AF is defined as AF where termination (sinus rhythm) is no longer pursued

• Have any condition that prevents placement of a catheter on the posterior wall of the left atrium

• History of Left Atrium (LA) infarction

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium.

Locations

Country	Name	City	State
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Maxwell Biomedical

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Complications related to acute SRT pacing protocol	Assessed post-procedure through hospital discharge (~7 days)
Primary	Ability of test system (MAX-SRS) to record AF	Record 1 run of AF = 60 seconds, categorical variable (Yes/No)	60 seconds
Primary	Mean SRT pacing duration per SRT pacing attempt	Record duration (min:sec) of each SRT pacing attempt	min:sec/attempt
Secondary	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.