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

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Procedure: Radiofrequency Ablation

• Registration Number: NCT01262443
• Lead Sponsor: Ettore Sansavini Health Science Foundation

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy Cool Flex catheter group	Radiofrequency Ablation	Therapy Cool Flex Catheter . No more available data

Primary Outcome Measures

Name	Time	Method
Percentual success of the procedure during the hospitalization	Up to 4 days	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 3 months from procedure	3 months	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 6 months from procedure	6 months	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.

Secondary Outcome Measures

Name	Time	Method
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.	Up to 4 days; 3-6 month
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given	Up to 4 days
Safety of the procedure	Up to 4 days	recording of procedure-related complications

Trial Locations

Locations (2)

Maria Cecilia Hospital; 🇮🇹 Cotignola, RA, Italy

Maria Pia Hospital; 🇮🇹 Torino, TO, Italy