Paroxysmal Atrial FibrillationPhase 2NCT00971204
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
A Phase 2 study testing CardioFocus HeartLight Endoscopic Ablation System in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 10 sites in United States.
Trial summary
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- CardioFocus HeartLight Endoscopic Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
Who cannot join
- overall good health as established by multiple criteria
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
University Of Virginia Health System
Charlottesville, Virginia, 22908
The Methodist Hospital Research Institute
Houston, Texas, 77030
Mt. Sinai Hospital
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
William Beaumont Hospital
Royal Oak, Michigan, 48072
Pacific Heart Institute
Santa Monica, California, 90404
About this study
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- CardioFocus HeartLight Endoscopic Ablation System
- Keywords
- atrial fibrillation, PAF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFocus HeartLight Endoscopic Ablation SystemDevice
PVI ablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment with HeartLight System | Experimental | Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System Receives: Device: CardioFocus HeartLight Endoscopic Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Recurrence of Atrial Fibrillation
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burke Barret, Study director, CardioFocus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971204
- Sponsor's protocol ID
- 25-2734
- Status last verified
- Jul 2016
- First submitted
- 2 Sep 2009
- Last updated
- 1 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00971204
- Acronym / sponsor ID
- 25-2734
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- atrial fibrillation, PAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Posted 27 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with HeartLight System | Experimental | Device: CardioFocus HeartLight Endoscopic Ablation SystemTreatment of paroxysmal atrial fibrillation (PAF) with HeartLight System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 70 years
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
Key exclusion criteria (1 listed)
- overall good health as established by multiple criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioFocus HeartLight Endoscopic Ablation SystemPVI ablation | Device | Treatment with HeartLight System |
Primary outcome
Freedom From Recurrence of Atrial Fibrillation
Time frame: 12 months
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Burke Barret study director
CardioFocus, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CardioFocus HeartLight Endoscopic Ablation System in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 10 sites in United States.
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 4 inclusion and 1 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Freedom From Recurrence of Atrial Fibrillation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2016.