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

NCT01408485 | Completed Results DMC

• 1 other identifier: 90067869
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 24

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.

Conditions

Typical Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (1)

• Secondary Efficacy

  3 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Device: Therapy™ Cool Flex™ Irrigated Ablation System

Interventions

Therapy™ Cool Flex™ Irrigated Ablation System 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

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 (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
• 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
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

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

Phoenix, Arizona, 85013, United States

Location

Summit - Cardiovascular Consultants Med Group, Inc.

Oakland, California, 94609, United States

Location

Huntington Memorial / Foothill Cardiology

Pasadena, California, 91105, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Community Memorial Hospital

Ventura, California, 93006, United States

Location

Adventist Health / Florida Hospital

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Washington Hospital Center

Georgetown, Maryland, 20010, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01835, United States

Location

Jersey Shore Universty Medical Center

Neptune City, New Jersey, 07753, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Cleveland Clinic / Cardiovascular Associates of Cleveland

Mayfield Heights, Ohio, 44124, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Sacred Heart Med Center

Springfield, Oregon, 97477, United States

Location

Guthrie-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Clinical Tex Research, LLC/DBA PharmaTex Research

Amarillo, Texas, 79106, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

VCAT / Royal Jubilee

Victoria, British Columbia, V8R 4R2, Canada

Location

Institut de Cardiologie de Quebec (Hopital Laval)

Québec, G1V 4G5, Canada

Location

Results Point of Contact

• Title: Nancy Ouch, Senior Clinical Project Manager
• Organization: St. Jude Medical

NOuch@sjm.com

949-769-5000

Study Officials

• Raul Weiss, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: August 3, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 15, 2019
• Results First Posted: June 23, 2014

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (22)