Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
STARLIGHT
1 other identifier
observational
25
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2013
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 5, 2014
March 1, 2014
10 months
January 8, 2013
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.
Acute - time of procedure
Study Arms (1)
Patients undergoing cardiac ablation for permanent AF
Eligibility Criteria
Permanent atrial fibrillation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Na Homolce
Prague, 15030, Czechia
Guys & St. Thomas' Hospital
London, SE1 1YR, United Kingdom
Related Publications (1)
Child N, Clayton RH, Roney CH, Laughner JI, Shuros A, Neuzil P, Petru J, Jackson T, Porter B, Bostock J, Niederer SA, Razavi RS, Rinaldi CA, Taggart P, Wright MJ, Gill J. Unraveling the Underlying Arrhythmia Mechanism in Persistent Atrial Fibrillation: Results From the STARLIGHT Study. Circ Arrhythm Electrophysiol. 2018 Jun;11(6):e005897. doi: 10.1161/CIRCEP.117.005897.
PMID: 29858382DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jas Gill, MA MD FRCP FACC
Guys & St. Thomas' Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 10, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 5, 2014
Record last verified: 2014-03