Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

NCT ID: NCT05461612

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SRT Pacing

SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm.

Group Type: EXPERIMENTAL

Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device

Intervention Type: DEVICE

Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SRT, MAX-SRS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxwell Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Khabeishvili, MD

Role: PRINCIPAL_INVESTIGATOR

Tbilisi Heart and Vascular Clinic

Locations

Tbilisi Heart and Vascular Clinic

Tbilisi, , Georgia

Site Status: RECRUITING

Countries

Georgia

Central Contacts

George Khabeishvili, MD

Role: CONTACT

georgekhabeishvili@icloud.com

+995 599 502 255

Elene Khabeishvili, MD

Role: CONTACT

EleneKhabeishvili@outlook.com

+995 555 737 300

Facility Contacts

Role: primary

heartvasc@hotmail.com

+995 322 479 300

Other Identifiers

CLP22-001

Identifier Type: -

Identifier Source: org_study_id