Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation (SR-TheAF)

Maxwell Biomedical

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05461612

CLP22-001

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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