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
  Purpose

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
Permanent Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. [ Time Frame: Acute - time of procedure ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing cardiac ablation for permanent AF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01765075     History of Changes
Other Study ID Numbers: STARLIGHT - 1012
Study First Received: January 8, 2013
Last Updated: March 3, 2014
Health Authority: United Kingdom: Research Ethics Committee
Czech Republic: Ethics Committee

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

ClinicalTrials.gov processed this record on April 22, 2014