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Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-density mapping guided ablation | Experimental | High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation. |
|
| Empirical linear ablation | Active Comparator | Empirical predefined set of linear ablation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrecuency ablation | Other | Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group. | Daily 1-lead 30 seconds ECG samples. | 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success. | Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min). | Acute intraprocedural. |
| Non-inducibility. |
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Inclusion criteria
Left atrial flutter1 inducible during electrophysiological evaluation.
Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
Informed consent.
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio C Castrejón, PhD | Contact | +34 659048245 | lapaz@arritmias.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital, Department of Cardiology | Recruiting | Madrid | Spain |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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1:1 parallell, randomized, controlled, open-label, single center clinical trial.
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Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.
| Acute intraprocedural. |
| Procedure duration. | From vein puncture up to seaths withdrawal. | Acute intraprocedural. |
| Left atrial dwell time. | From transeptal puncture up to catheters withdrawal from the left atrium. | Acute intraprocedural. |
| Safety. | Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism. | Acute a 1 month after ablation (procedure-related complications). |
| Hospitalization. | Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up. | 1 year. |