Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Typical Atrial Flutter Clinical Trial

Official title:

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984204
• Other study ID #: 90030638
• Status: Completed
• Phase: Phase 3
• Start date: October 2009
• Est. completion date: January 2012

Study information

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

Clinical Trial Summary

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Description:

This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM

Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: January 2012
• Est. primary completion date: August 2010
• 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 (cavotricuspid isthmus dependent)

• If subjects are receiving antiarrhythmic 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

• Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)

• Evidence of intracardiac thrombus or a history of clotting disorders

• Participation in another investigational study

• Cardiac surgery within 1 month of the intended procedure date

• Allergy or contraindication to Heparin

Related Conditions & MeSH terms

• Atrial Flutter
• Typical Atrial Flutter

Intervention

Device:
• Therapy Cool Path Duo
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Quebec	Quebec
Canada	Victoria Cardiac Arrhythmia Trials, Inc.	Victoria	British Columbia
United States	Virginia Hospital Center	Arlington	Virginia
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Ohio State Medical	Columbus	Ohio
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Moses Cone Hospital	Greensboro	North Carolina
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cardiovascular Associates of Cleveland	Mayfield Heights	Ohio
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Regional Cardiology Associates	Sacramento	California
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Main Line Health Center/Lankenau	Wynnewood	Pennsylvania

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 Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.		7 days
Primary	Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.		30 mins
Secondary	Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure		3 months