Paroxysmal Atrial Fibrillation Clinical Trial
— HeartLightOfficial title:
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
| Verified date | July 2015 |
| Source | CardioFocus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 405 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 18 to 75 years. - paroxysmal atrial fibrillation - failure of at least one AAD - others Exclusion Criteria: - overall good health as established by multiple criteria |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas |
| United States | Johns Hopkins | Baltimore | Maryland |
| United States | University of Alabama, Birmingham | Birminham | Alabama |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Medical University South Carolina | Charleston | South Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Duke University | Durham | North Carolina |
| United States | Methodist Hospital | Houston | Texas |
| United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
| United States | The University of Kansas Medical Center | Kansas City | Kansas |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Sentara Cardiovascular Research Institute | Norfolk | Virginia |
| United States | Mt. Sinai Hospital | NY | New York |
| United States | Stanford Hospital | Palo Alto | California |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Rochester/St. Mary's Hospital | Rochester | Minnesota |
| United States | Beaumont Hospital | Royal Oak | Michigan |
| United States | Regional Cardiology Associates, Mercy General Hospital | Sacramento | California |
| United States | UCSF | San Francisco | California |
| United States | Pacific Heart Institute | Santa Monica | California |
| United States | Prairie Heart Institute | Springfield | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| CardioFocus |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freedom for documented, symptomatic atrial fibrillation | Episodes of AF will be monitored during the follow-up period and the rate of subjects with no documented, symptomatic episodes of AF in follow-up will be compared. | 1 year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05970120 -
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
|
N/A | |
| Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
| Completed |
NCT03624881 -
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
|
Phase 4 | |
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Recruiting |
NCT05905835 -
Treatment of PAF With the Synaptic System
|
N/A | |
| Active, not recruiting |
NCT05618340 -
PFA for Paroxysmal Atrial Fibrillation
|
N/A | |
| Active, not recruiting |
NCT05534581 -
SINGLE SHOT CHAMPION
|
Phase 4 | |
| Not yet recruiting |
NCT05024630 -
Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension
|
N/A | |
| Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
| Completed |
NCT01913522 -
Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration
|
N/A | |
| Terminated |
NCT01925885 -
Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)
|
N/A | |
| Withdrawn |
NCT01917981 -
Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation
|
Phase 3 | |
| Completed |
NCT01693107 -
Atrial Fibrillation Force Contact Ablation Study
|
||
| Completed |
NCT01842529 -
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
|
Phase 2 | |
| Completed |
NCT00971204 -
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
|
Phase 2 | |
| Completed |
NCT05043883 -
Automated Assessment of PVI Using a Novel EP Recording System
|
N/A | |
| Recruiting |
NCT05172765 -
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
|
N/A | |
| Recruiting |
NCT04529785 -
Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation
|
N/A | |
| Completed |
NCT04022954 -
HD Mapping of Atrial Fibrillation in Asia Pacific
|
||
| Completed |
NCT00964392 -
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
|
Phase 4 |