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

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).

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Key information

Conditions

Typical Atrial Flutter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Victoria Cardiac Arrhythmia Trials, Inc., Victoria, British Columbia, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy Cool Path Duo

Device

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

Primary outcomes

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
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 outcomes

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

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2012
First posted: Sep 25, 2009
Registry last updated: Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed