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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Cool Flex catheter group | Experimental | Therapy Cool Flex Catheter . No more available data |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Procedure | Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Pappone, MD | Maria Cecilia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | RA | 48010 | Italy | ||
| Maria Pia Hospital |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Safety of the procedure | recording of procedure-related complications | Up to 4 days |
| Torino |
| TO |
| 10132 |
| Italy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |