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

Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Typical Atrial Flutter
• Intervention / Treatment: Device: Therapy™ Cool Flex™ Irrigated Ablation System

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut de Cardiologie de Quebec (Hôpital Laval)
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • VCAT / Royal Jubilee
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital-Heart Rhythm Specialists, PC
  • California
    • Oakland, California, United States, 94609
      • Summit - Cardiovascular Consultants Med Group, Inc.
    • Pasadena, California, United States, 91105
      • Huntington Memorial / Foothill Cardiology
    • Sacramento, California, United States, 95819
      • Regional Cardiology Associates
    • Ventura, California, United States, 93006
      • Community Memorial Hospital
  • Florida
    • Orlando, Florida, United States, 32803
      • Adventist Health / Florida Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital
  • Maryland
    • Georgetown, Maryland, United States, 20010
      • Washington Hospital Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01835
      • Lahey Clinic Medical Center
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore Universty Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic / Cardiovascular Associates of Cleveland
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Sacred Heart Med Center
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie-Robert Packer Hospital
  • Texas
    • Amarillo, Texas, United States, 79106
      • Clinical Tex Research, LLC/DBA PharmaTex Research
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Arm; Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System	Device: Therapy™ Cool Flex™ Irrigated Ablation System; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure	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.	7 days
Primary Efficacy	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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy	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.	3 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: July 22, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (ESTIMATE): August 3, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 90067869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO