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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01765075
First received: January 8, 2013
Last updated: March 3, 2014
Last verified: March 2014

January 8, 2013
March 3, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01765075 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Permanent atrial fibrillation

Permanent Atrial Fibrillation
Not Provided
Patients undergoing cardiac ablation for permanent AF
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   United Kingdom
 
NCT01765075
STARLIGHT - 1012
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP