Clinical trial NCT00984204: Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Official title: Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Typical Atrial Flutter
Keywords: cavo-tricuspid dependent
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Detailed description: This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM

Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

Eligibility criteria: Inclusion Criteria:

* A signed written Informed Consent
* 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:

* 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
* 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

Primary outcomes:
measure: Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.
timeFrame: 7 days
measure: Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.
timeFrame: 30 mins
Secondary outcomes:
measure: Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Medical
state: Ohio
city: Mayfield Heights
country: United States
facility: Cardiovascular Associates of Cleveland
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Center/Lankenau
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials, Inc.
state: British Columbia
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec
Study officials:
References: