Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
- Conditions
- Typical Atrial Flutter
- Interventions
- Device: Therapy™ Cool Flex™ Irrigated Ablation System
- Registration Number
- NCT01408485
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm Therapy™ Cool Flex™ Irrigated Ablation System Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System
- Primary Outcome Measures
Name Time Method Primary Efficacy 30 minutes Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure 7 days Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
- Secondary Outcome Measures
Name Time Method Secondary Efficacy 3 months Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.
Trial Locations
- Locations (24)
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
St. Joseph's Hospital-Heart Rhythm Specialists, PC
🇺🇸Phoenix, Arizona, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Cleveland Clinic / Cardiovascular Associates of Cleveland
🇺🇸Mayfield Heights, Ohio, United States
Clinical Tex Research, LLC/DBA PharmaTex Research
🇺🇸Amarillo, Texas, United States
Community Memorial Hospital
🇺🇸Ventura, California, United States
Summit - Cardiovascular Consultants Med Group, Inc.
🇺🇸Oakland, California, United States
Institut de Cardiologie de Quebec (Hopital Laval)
🇨🇦Quebec, Canada
Adventist Health / Florida Hospital
🇺🇸Orlando, Florida, United States
Sacred Heart Med Center
🇺🇸Springfield, Oregon, United States
Washington Hospital Center
🇺🇸Georgetown, Maryland, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Jersey Shore Universty Medical Center
🇺🇸Neptune, New Jersey, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
St. Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Guthrie-Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Huntington Memorial / Foothill Cardiology
🇺🇸Pasadena, California, United States
VCAT / Royal Jubilee
🇨🇦Victoria, British Columbia, Canada
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States