Clinical trial NCT01408485: Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
Official title: Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Typical Atrial Flutter
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
timeFrame: 7 days
measure: Primary Efficacy
timeFrame: 30 minutes
Secondary outcomes:
measure: Secondary Efficacy
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital-Heart Rhythm Specialists, PC
state: Arizona
city: Oakland
country: United States
facility: Summit - Cardiovascular Consultants Med Group, Inc.
state: California
city: Pasadena
country: United States
facility: Huntington Memorial / Foothill Cardiology
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Ventura
country: United States
facility: Community Memorial Hospital
state: California
city: Orlando
country: United States
facility: Adventist Health / Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Georgetown
country: United States
facility: Washington Hospital Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Neptune
country: United States
facility: Jersey Shore Universty Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic / Cardiovascular Associates of Cleveland
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Springfield
country: United States
facility: Sacred Heart Med Center
state: Oregon
city: Sayre
country: United States
facility: Guthrie-Robert Packer Hospital
state: Pennsylvania
city: Amarillo
country: United States
facility: Clinical Tex Research, LLC/DBA PharmaTex Research
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Victoria
country: Canada
facility: VCAT / Royal Jubilee
state: British Columbia
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hopital Laval)
Study officials:
affiliation: Ohio State University
name: Raul Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: