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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05063032
Other study ID # 5825 v 3.0, 3030th March 2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 28, 2022
Est. completion date October 1, 2024

Study information

Verified date January 2024
Source Hospital Universitario La Paz
Contact Sergio C Castrejón, PhD
Phone +34 659048245
Email lapaz@arritmias.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above. Exclusion criteria - Previous ablation of LAFL. - Previous linear ablation in the LA except for pulmonary vein isolation. - Absolute contraindication for oral anticoagulation. - Stroke or acute coronary syndrome less than 3 months before ablation. - Complex congenital heart disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Radiofrecuency ablation
Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.

Locations

Country Name City State
Spain La Paz University Hospital, Department of Cardiology Madrid

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Acute success. Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration =3 min). Acute intraprocedural.
Secondary Non-inducibility. Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure. Acute intraprocedural.
Secondary Procedure duration. From vein puncture up to seaths withdrawal. Acute intraprocedural.
Secondary Left atrial dwell time. From transeptal puncture up to catheters withdrawal from the left atrium. Acute intraprocedural.
Secondary Safety. Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism. Acute a 1 month after ablation (procedure-related complications).
Secondary Hospitalization. Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up. 1 year.
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