Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System

Completed · Phase 3

Conditions studied: Typical Atrial Flutter

In brief

To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result into unacceptable risk of intra-procedural composite serious adverse events and, * Does not affect efficacy of the ablation procedure The study will also evaluate the

Key facts

Study ID

NCT01401361

Run by

Abbott Medical Devices

People needed

150

Starts

2011-10-01

Expected to finish

2012-09-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A signed written Informed Consent
• Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
• If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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

You may not qualify if…

• Prior typical atrial flutter ablation treatment
• 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
• Clinically significant tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve.
• Evidence of intracardiac thrombus or a history of clotting disorders
• Participation in another investigational study
• Cardiac surgery within 1 month prior to the intended procedure date
• Allergy or contraindication to Heparin

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• Aurora Denver Cardiology — Denver, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• St. Vincent's Hospital — Jacksonville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• New York University Langone Medical Center - Tisch Hospital — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• Ohio Health Research Institute - GMC — Columbus, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Texas Health Research & Education Institute — Dallas, Texas, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• St. Luke's Episcopal Hospital — Houston, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Virginia Cardiovascular Specialists — Richmond, Virginia, United States
• Institut de Cardiologie de Montreal (Montreal Heart Inst.) — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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