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

Typical Atrial Flutter Clinical Trial

— FLEXION-AFL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408485
• Other study ID #: 90067869
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Typical Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Quebec (Hopital Laval)	Quebec
Canada	VCAT / Royal Jubilee	Victoria	British Columbia
United States	Clinical Tex Research, LLC/DBA PharmaTex Research	Amarillo	Texas
United States	St. Joseph's Hospital	Atlanta	Georgia
United States	Heart Hospital of Austin	Austin	Texas
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Washington Hospital Center	Georgetown	Maryland
United States	Methodist Hospital Research Institute	Houston	Texas
United States	Cleveland Clinic / Cardiovascular Associates of Cleveland	Mayfield Heights	Ohio
United States	Jersey Shore Universty Medical Center	Neptune	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	Summit - Cardiovascular Consultants Med Group, Inc.	Oakland	California
United States	Adventist Health / Florida Hospital	Orlando	Florida
United States	Huntington Memorial / Foothill Cardiology	Pasadena	California
United States	St. Joseph's Hospital-Heart Rhythm Specialists, PC	Phoenix	Arizona
United States	Regional Cardiology Associates	Sacramento	California
United States	Guthrie-Robert Packer Hospital	Sayre	Pennsylvania
United States	Sacred Heart Med Center	Springfield	Oregon
United States	Tampa General Hospital	Tampa	Florida
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Community Memorial Hospital	Ventura	California
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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