Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment (STARLIGHT)

Boston Scientific

Status: Completed

Conditions: Permanent Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT01765075

STARLIGHT - 1012

Details and patient eligibility

About

The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
• Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
• Able to meet study requirements for follow-up visit

Exclusion criteria

• Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
• Active systemic infection or sepsis
• Echocardiographically confirmed presence of thrombus
• Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
• Subjects who cannot be anticoagulated or infused with heparinized saline
• Heparin induced thrombocytopenia
• Hemodynamic instability or shock
• Atrial anatomy contradictory to catheter labeling or size indices
• EF < 35%
• Subjects with an active heart failure decompensation

Trial design

25 participants in 1 patient group

Patients undergoing cardiac ablation for permanent AF