Permanent Atrial FibrillationSTARLIGHTNCT01765075
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
An observational study of Permanent Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Permanent Atrial Fibrillation
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Permanent atrial fibrillation
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Hemodynamic instability or shock
- Atrial anatomy contradictory to catheter labeling or size indices
- EF < 35%
- Subjects with an active heart failure decompensation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Permanent Atrial Fibrillation
- Keywords
- Electrophysiological mapping, Multi-electrode catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac ablation for permanent AF | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.
Measured: Acute - time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Permanent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jas Gill, MA MD FRCP FACC, Principal investigator, Guys & St. Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765075
- Sponsor's protocol ID
- STARLIGHT - 1012
- Acronym
- STARLIGHT
- Status last verified
- Mar 2014
- First submitted
- 8 Jan 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29858382
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
- ClinicalTrials.gov ID
- NCT01765075
- Acronym / sponsor ID
- STARLIGHT / STARLIGHT - 1012
- Conditions
- Permanent Atrial Fibrillation
- Keywords
- Electrophysiological mapping, Multi-electrode catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac ablation for permanent AF | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Permanent atrial fibrillation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.
Time frame: Acute - time of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Derived from this study: PubMed 29858382Child 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jas Gill, MA MD FRCP FACC principal investigator
Guys & St. Thomas' Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Permanent Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. (time frame: Acute - time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.