Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation - Full Text View

Sponsor:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01185613

Purpose

The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.

Condition	Intervention	Phase
Paroxysmal Atrial Fibrillation	Device: Therapy™ Cool Flex Ablation Catheter	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Procedural parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Ablation parameters (such as average power delivered , average tip temperature , average impedance )
- Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location)
- Mapping techniques (Mapping system and catheter)
- RF application time ( Calculated from the total number of RF application and duration of each RF application)
- Ablation procedure time (Time from the first to the last RF application)
- Total irrigation fluid administered during ablation procedure
- Fluoroscopy time
AF Recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more.
- AF recurrences during the blanking period (defined below) will not be reported.
Serious Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
All serious adverse events through six month follow-up

Estimated Enrollment:	50
Study Start Date:	June 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Therapy™ Cool Flex Ablation Catheter	Device: Therapy™ Cool Flex Ablation Catheter The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes. The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher. Cool Point™ Irrigation Pump Cool Point™ Tubing set Data Logger

Arms

Assigned Interventions

Experimental: Therapy™ Cool Flex Ablation Catheter

Device: Therapy™ Cool Flex Ablation Catheter

The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes.

The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter

IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher.
Cool Point™ Irrigation Pump
Cool Point™ Tubing set
Data Logger

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 form
18 years of age or older
Agrees to comply with follow-up visits and evaluation
Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.

Exclusion Criteria:

Persistent or Long standing AF
CABG procedure within the last 180 days (six months).
Documented left atrial thrombus on imaging [e.g. Transesophageal echocardiogram (TEE)].
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e. heparin or warfarin).
Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
Acute illness or active systemic infection or sepsis.
Life expectancy less than 12 months.
Uncontrolled heart failure or NYHA class IV heart failure.
Myocardial Infarction within 8 weeks of enrollment or unstable angina

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185613

Locations

Australia
Royal Adelaide Hospital
Adelaide, Australia
France
Hopital du Haut Leveque
Pessac, France
Germany
Universitat Leipzig Herzzentrum
Leipzig, Germany
Italy
Ospendale dell'Angelo
Mestre, Italy
Portugal
Hospital Santa Cruz
Lisbon, Portugal
United Kingdom
Heart Hospital
London, United Kingdom

Sponsors and Collaborators

St. Jude Medical

More Information

No publications provided

Responsible Party:	Christophe Bailleul, SJM International, Inc.
ClinicalTrials.gov Identifier:	NCT01185613 History of Changes
Other Study ID Numbers:	AF-09-024-EU-AB
Study First Received:	August 18, 2010
Last Updated:	April 3, 2012
Health Authority:	Australia: Human Research Ethics Committee Germany: Federal Institute for Drugs and Medical Devices France: Institutional Ethical Committee United Kingdom: Research Ethics Committee Italy: Ethics Committee Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012