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

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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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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