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

NCT00984204 | Completed Phase 3 Results DMC

• 1 other identifier: 90030638
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 22

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).

Conditions

Typical Atrial Flutter

Keywords

cavo-tricuspid dependent

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (1)

• Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure

  3 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Device: Therapy Cool Path Duo

Interventions

Therapy Cool Path Duo DEVICE

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

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Agree to comply with follow-up visits and evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (22)

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

Location

Ohio State Medical

Columbus, Ohio, 43210, United States

Location

Cardiovascular Associates of Cleveland

Mayfield Heights, Ohio, 44124, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Main Line Health Center/Lankenau

Wynnewood, Pennsylvania, 19096, United States

Location

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Virginia Hospital Center

Arlington, Virginia, 22205, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Victoria Cardiac Arrhythmia Trials, Inc.

Victoria, British Columbia, V8R 4R2, Canada

Location

Institut de Cardiologie de Quebec

Québec, G1V 4G5, Canada

Location

Results Point of Contact

• Title: Nabil Kanaan
• Organization: St. Jude Medical

nkanaan@sjm.com

949-769-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 25, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2012
• Last Updated: February 19, 2019
• Results First Posted: December 20, 2013

Record last verified: 2019-02

Locations

US (20); CA (2)