Clinical trial NCT05461612: Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Official title: Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Spatial Resynchronization
Lead sponsor: Maxwell Biomedical
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ability of test system (MAX-SRS) to record AF
timeFrame: 60 seconds
measure: Mean SRT pacing duration per SRT pacing attempt
timeFrame: min:sec/attempt
Secondary outcomes:
measure: Mean SRT pacing duration to convert AF
timeFrame: Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.
Other outcomes:
measure: Complications
timeFrame: Assessed post-procedure through hospital discharge (~7 days)
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
Study officials:
affiliation: Tbilisi Heart and Vascular Clinic
name: George Khabeishvili, MD
role: PRINCIPAL_INVESTIGATOR
References: