Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation (SR-TheAF)

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Khabeishvili, MD; Phone Number: +995 599 502 255; Email: georgekhabeishvili@icloud.com
• Study Contact Backup: Name: Elene Khabeishvili, MD; Phone Number: +995 555 737 300; Email: EleneKhabeishvili@outlook.com

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Tbilisi Heart and Vascular Clinic
    • Contact: Phone Number: +995 322 479 300; Email: heartvasc@hotmail.com
    • Principal Investigator: George Khabeishvili, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRT Pacing; SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm.	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.; Other Names: SRT, MAX-SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications related to acute SRT pacing protocol	Assessed post-procedure through hospital discharge (~7 days)

Collaborators and Investigators

• Sponsor: Maxwell Biomedical
• Investigators: Principal Investigator: George Khabeishvili, MD, Tbilisi Heart and Vascular Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Spatial Resynchronization
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLP22-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No