Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Primary Purpose
Typical Atrial Flutter
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Therapy Cool Path Duo
Sponsored by
About this trial
This is an interventional treatment trial for Typical Atrial Flutter focused on measuring cavo-tricuspid dependent
Eligibility Criteria
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
Sites / Locations
- Regional Cardiology Associates
- Kansas University Medical Center
- Central Baptist Hospital
- Ochsner Medical Center
- Washington Adventist Hospital
- Lahey Clinic Medical Center
- University of Rochester
- Carolinas Medical Center
- Moses Cone Hospital
- Ohio State Medical
- Cardiovascular Associates of Cleveland
- Providence St. Vincent Medical Center
- Doylestown Hospital
- Main Line Health Center/Lankenau
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital
- St. Luke's Episcopal Hospital
- The Methodist Hospital
- Scott & White Memorial Hospital
- Virginia Hospital Center
- University of Virginia Medical Center
- Victoria Cardiac Arrhythmia Trials, Inc.
- Institut de Cardiologie de Quebec
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
Full Information
NCT ID
NCT00984204
First Posted
September 22, 2009
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00984204
Brief Title
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Official Title
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 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
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).
Detailed 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter
Keywords
cavo-tricuspid dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Therapy Cool Path Duo
Intervention Description
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
Primary Outcome Measure Information:
Title
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.
Time Frame
7 days
Title
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.
Time Frame
30 mins
Secondary Outcome Measure Information:
Title
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
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 (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
Facility Information:
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Moses Cone Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Ohio State Medical
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cardiovascular Associates of Cleveland
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Main Line Health Center/Lankenau
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
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
Virginia Hospital Center
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Victoria Cardiac Arrhythmia Trials, Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Institut de Cardiologie de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
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