Back to resultsInitial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation (SR-TheAF)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Spatial Resynchronization
Eligibility Criteria
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
Sites / Locations
- Tbilisi Heart and Vascular ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SRT Pacing
Arm Description
SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm.
Outcomes
Primary Outcome Measures
Ability of test system (MAX-SRS) to record AF
Record 1 run of AF = 60 seconds, categorical variable (Yes/No)
Mean SRT pacing duration per SRT pacing attempt
Record duration (min:sec) of each SRT pacing attempt
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461612
Brief Title
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Acronym
SR-TheAF
Official Title
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maxwell Biomedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Spatial Resynchronization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SRT Pacing
Arm Type
Experimental
Arm Description
SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm.
Intervention Type
Device
Intervention Name(s)
Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
Other Intervention Name(s)
SRT, MAX-SRS
Intervention Description
Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium.
Primary Outcome Measure Information:
Title
Ability of test system (MAX-SRS) to record AF
Description
Record 1 run of AF = 60 seconds, categorical variable (Yes/No)
Time Frame
60 seconds
Title
Mean SRT pacing duration per SRT pacing attempt
Description
Record duration (min:sec) of each SRT pacing attempt
Time Frame
min:sec/attempt
Secondary Outcome Measure Information:
Title
Mean SRT pacing duration to convert AF
Description
Record duration (min:sec) of SRT pacing and organization of clinical rhythm (conversion to arrhythmia other than AF) or AF termination.
Time Frame
Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.
Other Pre-specified Outcome Measures:
Title
Complications
Description
Complications related to acute SRT pacing protocol
Time Frame
Assessed post-procedure through hospital discharge (~7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Khabeishvili, MD
Phone
+995 599 502 255
Email
georgekhabeishvili@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elene Khabeishvili, MD
Phone
+995 555 737 300
Email
EleneKhabeishvili@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Khabeishvili, MD
Organizational Affiliation
Tbilisi Heart and Vascular Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
+995 322 479 300
Email
heartvasc@hotmail.com
First Name & Middle Initial & Last Name & Degree
George Khabeishvili, MD
12. IPD Sharing Statement
Learn more about this trial
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
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