Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

NCT ID: NCT01262443

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Detailed Description

No more available data

Conditions

Atrial Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapy Cool Flex catheter group

Therapy Cool Flex Catheter . No more available data

Group Type: EXPERIMENTAL

Radiofrequency Ablation

Intervention Type: PROCEDURE

Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Interventions

Radiofrequency Ablation

Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Both sexes; age>18 yrs
• ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
• No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
• Patients willing to accept the tests and to follow standard procedures
• Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment

Exclusion Criteria

• Atrial fibrillation
• Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
• Intra atrial thrombosis
• NYHA class IV
• Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
• Untreated Wolf Parkinson White syndrome
• Contraindications to oral anticoagulation
• Life expectancy < 12 month
• Major surgery or interventional procedure already planned in the 6 month following ablation
• Pregnancy or breast-feeding
• Participation in another study

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

Sponsors

Ettore Sansavini Health Science Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

Maria Cecilia Hospital

Cotignola, RA, Italy

Maria Pia Hospital

Torino, TO, Italy

Countries

Italy

Other Identifiers

ESREFO01

Identifier Type: -

Identifier Source: org_study_id