Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Phase 2

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Therapy™ Cool Flex Ablation Catheter

• Registration Number: NCT01185613
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-20
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy™ Cool Flex Ablation Catheter	Therapy™ Cool Flex Ablation Catheter	-

Primary Outcome Measures

Name	Time	Method
Procedural parameters	6 months	* 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
Serious Adverse Events	6 months	All serious adverse events through six month follow-up
AF Recurrence	6 months	* 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.

Trial Locations

Locations (6)

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Universitat Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany

Hopital du Haut Leveque; 🇫🇷 Pessac, France

Ospendale dell'Angelo; 🇮🇹 Mestre, Italy

Hospital Santa Cruz; 🇵🇹 Lisbon, Portugal

Heart Hospital; 🇬🇧 London, United Kingdom