Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (FACT-AF)

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Therapy™ Cool Flex Ablation Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
• France
  • Pessac, France
    • Hopîtal du Haut Lévêque
• Germany
  • Leipzig, Germany
    • Universität Leipzig Herzzentrum
• Italy
  • Mestre, Italy
    • Ospendale dell'Angelo
• Portugal
  • Lisbon, Portugal
    • Hospital Santa Cruz
• United Kingdom
  • London, United Kingdom
    • Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural parameters	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	6 months
AF Recurrence	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.	6 months
Serious Adverse Events	All serious adverse events through six month follow-up	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF-09-024-EU-AB