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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014