Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation

NCT05461612 | Unknown

• 1 other identifier: CLP22-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Spatial Resynchronization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mean SRT pacing duration to convert AF

  Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.

Other Outcomes (1)

• Complications

  Assessed post-procedure through hospital discharge (~7 days)

Study Arms (1)

SRT Pacing

EXPERIMENTAL

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

Interventions

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

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

Also known as: SRT, MAX-SRS

SRT Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have active pericarditis or any systemic infection
• Have left atrial thrombus (including left atrial appendage)
• Have had a previous attempt to ablate atrial fibrillation
• 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

Sponsors & Collaborators

• Maxwell Biomedical: lead

Study Sites (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George Khabeishvili, MD

  Tbilisi Heart and Vascular Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Khabeishvili, MD

CONTACT

+995 599 502 255; georgekhabeishvili@icloud.com

Elene Khabeishvili, MD

CONTACT

+995 555 737 300; EleneKhabeishvili@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 18, 2022
• Study Start: June 23, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

GE (1)