Paroxysmal Atrial FibrillationPhase 3HeartLightNCT01456000
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
A Phase 3 study testing EAS-AC (HeartLight) in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 21 sites in United States.
Trial summary
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- EAS-AC (HeartLight)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2012to Jan 2016
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 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
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Johns Hopkins
Baltimore, Maryland, 21287
University of Alabama, Birmingham
Birminham, Alabama
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University South Carolina
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27710
Methodist Hospital
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865
The University of Kansas Medical Center
Kansas City, Kansas
Intermountain Medical Center
Murray, Utah
Mt. Sinai Hospital
New York, New York, 10029
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Stanford Hospital
Palo Alto, California, 94305
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Rochester/St. Mary's Hospital
Rochester, Minnesota, 55902
Beaumont Hospital
Royal Oak, Michigan, 48072
Regional Cardiology Associates, Mercy General Hospital
Sacramento, California, 95819
UCSF
San Francisco, California, 94143
Pacific Heart Institute
Santa Monica, California, 90404
Prairie Heart Institute
Springfield, Illinois, 62701
About this study
Official title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
Read the detailed description
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- EAS-AC (HeartLight), Control Arm Ablation
- Keywords
- atrial fibrillation, AF, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAS-AC (HeartLight)Device
Pulmonary vien isolation
Control Arm AblationProcedure or surgery
Treatment with standard ablation.
| Study group | Role | What they receive |
|---|---|---|
| EAS-AC (HeartLight) | Experimental | Treatment with the EAS-AC. Receives: Device: EAS-AC (HeartLight) |
| Control Arm Ablation | Active comparator | Treatment with standard ablation. Receives: Procedure: Control Arm Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionJan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burke Barrett, Study director, CardioFocus, Inc. (sponsor)Vivek Reddy, MD, Principal investigator, Mt. Sinai Hospital, NYCAndrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456000
- Sponsor's protocol ID
- 25-3002
- Acronym
- HeartLight
- Status last verified
- Jul 2016
- First submitted
- 17 Oct 2011
- Last updated
- 8 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY; HeartLight Study Investigators. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.
PubMed 26383722
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01456000
- Acronym / sponsor ID
- HeartLight / 25-3002
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- atrial fibrillation, AF, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 8 Sep 2016
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 this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
Detailed description
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAS-AC (HeartLight) | Experimental | Device: EAS-AC (HeartLight)Treatment with the EAS-AC. |
| Control Arm Ablation | Active comparator | Procedure: Control Arm AblationTreatment with standard ablation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 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 |
|---|---|---|
| EAS-AC (HeartLight)Pulmonary vien isolation | Device | EAS-AC (HeartLight) |
| Control Arm AblationTreatment with standard ablation. | Procedure or surgery | Control Arm Ablation |
Primary outcome
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
Time frame: 1 year
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26383722Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY; HeartLight Study Investigators. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.
- Individual participant dataSharing planned: No
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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 Barrett study director
CardioFocus, Inc. (sponsor)
Vivek Reddy, MD principal investigator
Mt. Sinai Hospital, NYC
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EAS-AC (HeartLight) in people with Paroxysmal Atrial Fibrillation, run by CardioFocus at 21 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 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Sep 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?
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description (time frame: 1 year). 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 NCT01456000, 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 8 Sep 2016.