Back to resultsEfficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiofrequency Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial flutter
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
Sites / Locations
- Maria Cecilia Hospital
- Maria Pia Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapy Cool Flex catheter group
Arm Description
Therapy Cool Flex Catheter . No more available data
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given
Safety of the procedure
recording of procedure-related complications
Full Information
NCT ID
NCT01262443
First Posted
December 13, 2010
Last Updated
September 30, 2016
Sponsor
Ettore Sansavini Health Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01262443
Brief Title
Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ettore Sansavini Health Science Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Atrial flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy Cool Flex catheter group
Arm Type
Experimental
Arm Description
Therapy Cool Flex Catheter . No more available data
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Description
Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
Primary Outcome Measure Information:
Title
Percentual success of the procedure during the hospitalization
Description
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.
Time Frame
Up to 4 days
Title
Percentual success of the procedure at 3 months from procedure
Description
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.
Time Frame
3 months
Title
Percentual success of the procedure at 6 months from procedure
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.
Time Frame
Up to 4 days; 3-6 month
Title
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given
Time Frame
Up to 4 days
Title
Safety of the procedure
Description
recording of procedure-related complications
Time Frame
Up to 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD
Organizational Affiliation
Maria Cecilia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
RA
ZIP/Postal Code
48010
Country
Italy
Facility Name
Maria Pia Hospital
City
Torino
State/Province
TO
ZIP/Postal Code
10132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip
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