Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

Completed · Not applicable

Conditions studied: Typical Atrial Flutter

In brief

To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

Key facts

Study ID

NCT01408485

Run by

Abbott Medical Devices

People needed

200

Starts

2011-11-01

Expected to finish

2012-10-01

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 anti-arrhythmic 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

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 intra-cardiac 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

• St. Joseph's Hospital-Heart Rhythm Specialists, PC — Phoenix, Arizona, United States
• Summit - Cardiovascular Consultants Med Group, Inc. — Oakland, California, United States
• Huntington Memorial / Foothill Cardiology — Pasadena, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Community Memorial Hospital — Ventura, California, United States
• Adventist Health / Florida Hospital — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Joseph's Hospital — Atlanta, Georgia, United States
• Washington Hospital Center — Georgetown, Maryland, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Jersey Shore Universty Medical Center — Neptune City, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Cleveland Clinic / Cardiovascular Associates of Cleveland — Mayfield Heights, Ohio, United States
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States
• Sacred Heart Med Center — Springfield, Oregon, United States
• Guthrie-Robert Packer Hospital — Sayre, Pennsylvania, United States
• Clinical Tex Research, LLC/DBA PharmaTex Research — Amarillo, Texas, United States
• Heart Hospital of Austin — Austin, Texas, United States
• Methodist Hospital Research Institute — Houston, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• VCAT / Royal Jubilee — Victoria, British Columbia, Canada
• Institut de Cardiologie de Quebec (Hopital Laval) — Québec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.