CompletedPhase 3

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

United States188 participantsStarted 2009-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 surger…

What they're measuring

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

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

Trial details

NCT IDNCT00984204

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2013-11-01

View on ClinicalTrials.gov More Typical Atrial Flutter trials