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

NCT ID: NCT01408485

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Typical Atrial Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

Therapy™ Cool Flex™ Irrigated Ablation System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raul Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

St. Joseph's Hospital-Heart Rhythm Specialists, PC

Phoenix, Arizona, United States

Summit - Cardiovascular Consultants Med Group, Inc.

Oakland, California, United States

Huntington Memorial / Foothill Cardiology

Pasadena, California, United States

Regional Cardiology Associates

Sacramento, California, United States

Community Memorial Hospital

Ventura, California, United States

Adventist Health / Florida Hospital

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

St. Joseph's Hospital

Atlanta, Georgia, United States

Washington Hospital Center

Georgetown, Maryland, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Jersey Shore Universty Medical Center

Neptune City, New Jersey, United States

Mount Sinai School of Medicine

New York, New York, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Cleveland Clinic / Cardiovascular Associates of Cleveland

Mayfield Heights, Ohio, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Sacred Heart Med Center

Springfield, Oregon, United States

Guthrie-Robert Packer Hospital

Sayre, Pennsylvania, United States

Clinical Tex Research, LLC/DBA PharmaTex Research

Amarillo, Texas, United States

Heart Hospital of Austin

Austin, Texas, United States

Methodist Hospital Research Institute

Houston, Texas, United States

Scott & White Memorial Hospital

Temple, Texas, United States

VCAT / Royal Jubilee

Victoria, British Columbia, Canada

Institut de Cardiologie de Quebec (Hopital Laval)

Québec, , Canada

Countries

United States; Canada

Other Identifiers

90067869

Identifier Type: -

Identifier Source: org_study_id