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

Purpose

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).

Condition	Intervention	Phase
Typical Atrial Flutter	Device: Therapy Cool Path Duo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Further study details as provided by St. Jude Medical:

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. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy- Freedom from recurrence of typical atrial flutter up to 3 months post procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	188
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment arm	Device: Therapy Cool Path Duo All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984204

Show 22 Study Locations

Sponsors and Collaborators

St. Jude Medical

More Information

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00984204 History of Changes
Other Study ID Numbers:	90030638
Study First Received:	September 22, 2009
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

cavo-tricuspid dependent

Additional relevant MeSH terms:

Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013