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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765075
First Posted: January 10, 2013
Last Update Posted: March 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
January 8, 2013
January 10, 2013
March 5, 2014
April 2013
February 2014   (Final data collection date for primary outcome measure)
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. [ Time Frame: Acute - time of procedure ]
Same as current
Complete list of historical versions of study NCT01765075 on ClinicalTrials.gov Archive Site
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Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
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.
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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample
Permanent atrial fibrillation
Permanent Atrial Fibrillation
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Patients undergoing cardiac ablation for permanent AF
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   United Kingdom
 
 
NCT01765075
STARLIGHT - 1012
No
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Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Jas Gill, MA MD FRCP FACC Guys & St. Thomas' Hospital
Boston Scientific Corporation
March 2014