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

NCT ID: NCT01185613

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Therapy™ Cool Flex Ablation Catheter

Group Type: EXPERIMENTAL

Therapy™ Cool Flex Ablation Catheter

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

SJM International, Inc.

Locations

Royal Adelaide Hospital

Adelaide, , Australia

Hopital du Haut Leveque

Pessac, , France

Universitat Leipzig Herzzentrum

Leipzig, , Germany

Ospendale dell'Angelo

Mestre, , Italy

Hospital Santa Cruz

Lisbon, , Portugal

Heart Hospital

London, , United Kingdom

Countries

Australia; France; Germany; Italy; Portugal; United Kingdom

Other Identifiers

AF-09-024-EU-AB

Identifier Type: -

Identifier Source: org_study_id