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

Atrial Flutter Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262443
• Other study ID #: ESREFO01
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: September 30, 2016
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Ettore Sansavini Health Science Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

No more available data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Procedure:
• Radiofrequency Ablation
Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	RA
Italy	Maria Pia Hospital	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.		Up to 4 days; 3-6 month	No
Secondary	Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given		Up to 4 days	Yes
Secondary	Safety of the procedure	recording of procedure-related complications	Up to 4 days	Yes