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

Paroxysmal Atrial Fibrillation Clinical Trial

— FACT-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185613
• Other study ID #: AF-09-024-EU-AB
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Serious Adverse Events	All serious adverse events through six month follow-up	6 months