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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Adelaide Hospital, Adelaide, Australia

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 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

Treatment and study plan

Therapy™ Cool Flex Ablation Catheter

Device

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

Primary outcomes

Procedural parameters

Time frame: 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
AF Recurrence

Time frame: 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.
Serious Adverse Events

Time frame: 6 months

All serious adverse events through six month follow-up

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: FACT-AF

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 20, 2010
Registry last updated: Feb 4, 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