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Completed

NCT Number: NCT01408485

Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

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.

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Key information

Conditions

Typical Atrial Flutter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VCAT / Royal Jubilee, Victoria, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy™ Cool Flex™ Irrigated Ablation System

Device

The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:

  • Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
  • IBI 1500T9 V1.43 RF Generator

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Secondary Efficacy

    Time frame: 3 months

    Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter

Acronym: FLEXION-AFL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2011
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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