Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

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

Detailed Description
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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.

Official Title
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Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRT Pacing<br>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<br>* Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium.<br>* Other names: SRT, MAX-SRS;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Spatial Resynchronization