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

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: July 22, 2011
Last updated: April 21, 2017
Last verified: May 2014
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.

Condition Intervention
Typical Atrial Flutter Device: Therapy™ Cool Flex™ Irrigated Ablation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

Enrollment: 200
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01408485

  Show 24 Study Locations
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Raul Weiss, MD Ohio State University
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01408485     History of Changes
Other Study ID Numbers: 90067869
Study First Received: July 22, 2011
Results First Received: January 22, 2014
Last Updated: April 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 19, 2017