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

Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Procedure: Radiofrequency Ablation

Detailed Description

No more available data

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RA
    • Cotignola, RA, Italy, 48010
      • Maria Cecilia Hospital
  • TO
    • Torino, TO, Italy, 10132
      • Maria Pia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy Cool Flex catheter group; Therapy Cool Flex Catheter . No more available data	Procedure: Radiofrequency Ablation; Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentual success of the procedure during the hospitalization	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.	Up to 4 days
Percentual success of the procedure at 3 months from procedure	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.	3 months
Percentual success of the procedure at 6 months from procedure	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
•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	recording of procedure-related complications	Up to 4 days

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation
• Investigators: Principal Investigator: Carlo Pappone, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Atrial flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: ESREFO01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO