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

NCT01185613 | Completed Phase 2

• 1 other identifier: AF-09-024-EU-AB
• Study Type: interventional
• Target: 50
• Locations: 6 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Therapy™ Cool Flex Ablation Catheter

EXPERIMENTAL

Device: Therapy™ Cool Flex Ablation Catheter

Interventions

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

Therapy™ Cool Flex Ablation Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed written Informed Consent form
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Royal Adelaide Hospital

Adelaide, Australia

Location

Hopital du Haut Leveque

Pessac, France

Location

Universitat Leipzig Herzzentrum

Leipzig, Germany

Location

Ospendale dell'Angelo

Mestre, Italy

Location

Hospital Santa Cruz

Lisbon, Portugal

Location

Heart Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 20, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

PT (1); FR (1); GB (1); AU (1); DE (1); IT (1)