Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter (FLEXION-AFL)

Abbott

Status: Completed

Conditions: Typical Atrial Flutter

Treatments: Device: Therapy™ Cool Flex™ Irrigated Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408485

90067869

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System

Treatment:

Device: Therapy™ Cool Flex™ Irrigated Ablation System