Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAS-AC (HeartLight) | Experimental | Treatment with the EAS-AC. |
|
| Control Arm Ablation | Active Comparator | Treatment with standard ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EAS-AC (HeartLight) | Device | Pulmonary vien isolation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Burke Barrett | CardioFocus, Inc. (sponsor) | Study Director |
| Vivek Reddy, MD | Mt. Sinai Hospital, NYC | Principal Investigator |
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birminham | Alabama | United States | |||
| Stanford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26383722 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There were 405 participants enrolled in the study. Thirty nine of these participants were enrolled in the run-in phase and are not reported in the pivotal data. Of the remaining 366 enrolled participants, 13 were excluded from the study prior to randomization, resulting in a total of 353 randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EAS-AC (HeartLight) | Treatment with the EAS-AC. EAS-AC (HeartLight): Pulmonary vien isolation ITT Population 178 participants |
| FG001 | Control Arm Ablation | Treatment with standard ablation. Control Arm Ablation: Treatment with standard ablation. ITT Population 175 Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Arm Ablation |
| Procedure |
Treatment with standard ablation. |
|
| Palo Alto |
| California |
| 94305 |
| United States |
| Regional Cardiology Associates, Mercy General Hospital | Sacramento | California | 95819 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224-1865 | United States |
| Prairie Heart Institute | Springfield | Illinois | 62701 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48072 | United States |
| Mayo Clinic Rochester/St. Mary's Hospital | Rochester | Minnesota | 55902 | United States |
| Mt. Sinai Hospital | New York | New York | 10029 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Average Age
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EAS-AC (HeartLight) | Treatment with the EAS-AC. Randomized and treated cohort. EAS-AC (HeartLight): Pulmonary vien isolation |
| BG001 | Control Arm Ablation | Treatment with standard ablation. Randomized and treated cohort. Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Successful Participants | 1 year |
|
|
|
1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EAS-AC (HeartLight) | Treatment with the EAS-AC. EAS-AC (HeartLight): Pulmonary vien isolation ITT Population 178 participants | 16 | 170 | 92 | 170 | ||
| EG001 | Control Arm Ablation | Treatment with standard ablation. Control Arm Ablation: Treatment with standard ablation. ITT Population 175 Participants | 10 | 172 | 105 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac perforation, pericardial effusion or tamponade | Cardiac disorders | Systematic Assessment |
| ||
| CVA or stroke | Nervous system disorders | Systematic Assessment | cerebrovascular event or stroke |
| |
| Chest pain or pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Diaphragmatic paralysis or phrenic nerve injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hemorrhage or pseudoaneurysm | Vascular disorders | Systematic Assessment |
| ||
| Other | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardioversion | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain/discomfort | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Other | Cardiac disorders | Systematic Assessment | All other events reported below the 5% reporting threshold. |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Burke Barrett, VP Regulatory & Clinical Affairs | CardioFocus, Inc. | 508 658-7200 | bbarrett@cardiofocus.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|