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

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ClinicalTrials.gov Identifier: NCT01765075
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease
Permanent Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Patients undergoing cardiac ablation for permanent AF



Primary Outcome Measures :
  1. Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. [ Time Frame: Acute - time of procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Permanent atrial fibrillation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765075


Locations
Czech Republic
Na Homolce
Prague, Czech Republic, 15030
United Kingdom
Guys & St. Thomas' Hospital
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Jas Gill, MA MD FRCP FACC Guys & St. Thomas' Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01765075     History of Changes
Other Study ID Numbers: STARLIGHT - 1012
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Boston Scientific Corporation:
Electrophysiological mapping
Multi-electrode catheter

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes