Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Permanent Atrial Fibrillation Clinical Trial

— STARLIGHT  

Official title:

Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765075
• Other study ID #: STARLIGHT - 1012
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: March 3, 2014
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeCzech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation
• Permanent Atrial Fibrillation

Locations

Country	Name	City	State
Czech Republic	Na Homolce	Prague
United Kingdom	Guys & St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Czech Republic,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.		Acute - time of procedure	No