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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01408485
First received: July 22, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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 / Acute Success [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Primary efficacy / Acute success is defined as the ability to obtain bi-directional block in the cavo-tricuspid isthmus and noninducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the Therapy™ Cool Flex™ Catheter Ablation System.


Secondary Outcome Measures:
  • Secondary Efficacy / Chronic Success [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Secondary efficacy / Chronic success is defined as freedom from the recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence can be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmia medication (Class 1a, 1c, III) during the 3 months 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408485

  Show 25 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Raul Weiss, MD Ohio State University
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01408485     History of Changes
Other Study ID Numbers: 90067869
Study First Received: July 22, 2011
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014