Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
NCT ID: NCT00984204
Last Updated: 2019-02-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
188 participants
INTERVENTIONAL
2009-10-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
NCT01408485
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
NCT01401361
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
NCT00213408
Cryoablation as Standard Treatment of Atrial Flutter
NCT01604369
Therapy of Atrial Flutter by Afib Ablation
NCT02051621
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment arm
Therapy Cool Path Duo
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapy Cool Path Duo
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of typical atrial flutter (cavotricuspid isthmus dependent)
* If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
* One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
* In good physical health
* 18 years of age or older
* Agree to comply with follow-up visits and evaluation
Exclusion Criteria
* Pregnancy
* Atypical flutter or scar flutter(non-isthmus dependent)
* Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
* A recent myocardial infarction within 3 months of the intended procedure date
* Permanent coronary sinus pacing lead
* Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
* Evidence of intracardiac thrombus or a history of clotting disorders
* Participation in another investigational study
* Cardiac surgery within 1 month of the intended procedure date
* Allergy or contraindication to Heparin
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regional Cardiology Associates
Sacramento, California, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
University of Rochester
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Moses Cone Hospital
Greensboro, North Carolina, United States
Ohio State Medical
Columbus, Ohio, United States
Cardiovascular Associates of Cleveland
Mayfield Heights, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Main Line Health Center/Lankenau
Wynnewood, Pennsylvania, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Virginia Hospital Center
Arlington, Virginia, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, Canada
Institut de Cardiologie de Quebec
Québec, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
90030638
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.