Prospective Study to Evaluate the Efficacy of Transcatheter Ablation of Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip. The FLEX STUDY
This study is currently recruiting participants.
Verified July 2012 by Ettore Sansavini Health Science Foundation
Sponsor:
Ettore Sansavini Health Science Foundation
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01262443
First received: December 13, 2010
Last updated: February 25, 2013
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atrial Flutter |
Procedure: Radiofrequency Ablation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Further study details as provided by Ettore Sansavini Health Science Foundation:
Primary Outcome Measures:
- Percentual success of the procedure during the hospitalization [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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. [ Time Frame: Up to 4 days; 3-6 month ] [ Designated as safety issue: No ]
- Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given [ Time Frame: Up to 4 days ] [ Designated as safety issue: Yes ]
- Safety of the procedure [ Time Frame: Up to 4 days ] [ Designated as safety issue: Yes ]recording of procedure-related complications
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Therapy Cool Flex catheter group
Therapy Cool Flex Catheter
|
Procedure: Radiofrequency Ablation
Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262443
Locations
| Italy | |
| Maria Cecilia Hospital | Recruiting |
| Cotignola, RA, Italy, 48010 | |
| Contact: Luca Dozza +390545217 ext 175 ldozza@esrefo.org | |
| Principal Investigator: Carlo Pappone, MD | |
| Maria Pia Hospital | Recruiting |
| Torino, TO, Italy, 10132 | |
| Contact: Cristina Maria Jori, MD +390545217 ext 031 mcjori@esrefo.org | |
| Principal Investigator: Bruno Pezzulich, MD | |
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
More Information
No publications provided
| Responsible Party: | Ettore Sansavini Health Science Foundation |
| ClinicalTrials.gov Identifier: | NCT01262443 History of Changes |
| Other Study ID Numbers: | ESREFO01 |
| Study First Received: | December 13, 2010 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Ettore Sansavini Health Science Foundation:
|
Atrial flutter |
Additional relevant MeSH terms:
|
Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013