Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 24
- Primary Endpoint
- Primary Efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Arm
Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System
Intervention: Therapy™ Cool Flex™ Irrigated Ablation System (Device)
Outcomes
Primary Outcomes
Primary Efficacy
Time Frame: 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
Time Frame: 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 Outcomes
- Secondary Efficacy(3 months)