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

Primary Purpose

Typical Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Therapy™ Cool Flex™ Irrigated Ablation System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typical Atrial Flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph's Hospital-Heart Rhythm Specialists, PC
  • Summit - Cardiovascular Consultants Med Group, Inc.
  • Huntington Memorial / Foothill Cardiology
  • Regional Cardiology Associates
  • Community Memorial Hospital
  • Adventist Health / Florida Hospital
  • Tampa General Hospital
  • St. Joseph's Hospital
  • Washington Hospital Center
  • Lahey Clinic Medical Center
  • Jersey Shore Universty Medical Center
  • Mount Sinai School of Medicine
  • Forsyth Medical Center
  • Ohio State University Medical Center
  • Cleveland Clinic / Cardiovascular Associates of Cleveland
  • Oklahoma Heart Institute
  • Sacred Heart Med Center
  • Guthrie-Robert Packer Hospital
  • Clinical Tex Research, LLC/DBA PharmaTex Research
  • Heart Hospital of Austin
  • Methodist Hospital Research Institute
  • Scott & White Memorial Hospital
  • VCAT / Royal Jubilee
  • Institut de Cardiologie de Quebec (Hopital Laval)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 22, 2011
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01408485
Brief Title
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
Acronym
FLEXION-AFL
Official Title
Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System
Intervention Type
Device
Intervention Name(s)
Therapy™ Cool Flex™ Irrigated Ablation System
Intervention Description
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 Outcome Measure Information:
Title
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
Description
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.
Time Frame
7 days
Title
Primary Efficacy
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Secondary Efficacy
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Weiss, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital-Heart Rhythm Specialists, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Summit - Cardiovascular Consultants Med Group, Inc.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Huntington Memorial / Foothill Cardiology
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Community Memorial Hospital
City
Ventura
State/Province
California
ZIP/Postal Code
93006
Country
United States
Facility Name
Adventist Health / Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Washington Hospital Center
City
Georgetown
State/Province
Maryland
ZIP/Postal Code
20010
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01835
Country
United States
Facility Name
Jersey Shore Universty Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cleveland Clinic / Cardiovascular Associates of Cleveland
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Sacred Heart Med Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Guthrie-Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Clinical Tex Research, LLC/DBA PharmaTex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
VCAT / Royal Jubilee
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Institut de Cardiologie de Quebec (Hopital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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