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NCT06046352 Clinical Trial

Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia

Supraventricular Tachycardia Clinical Trial

— BELIEVE-SVT  

Official title:
Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06046352
Other study ID # 19/562
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2019
Est. completion date June 1, 2022

Study information
Verified date September 2023
Source Hospital Universitario 12 de Octubre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

BELIEVE-SVT is a European multi-centre, retrospective registry in tertiary hospitals performing electrophysiological study in patients with palpitations considered clinically suggestive of paroxysmal supraventricular tachycardia by a cardiologist and without electrocardiographic documentation of tachycardia or preexcitation. Clinical characteristics, results of electrophysiological study and ablation, complications, and clinical outcomes during follow-up will be analysed.

Description:

The "Symptom Burden As Guiding Principle For Invasive Electrophysiological Study In Paroxysmal Supraventricular Tachycardia (Believe-SVT)" study was a multi-centre, retrospective, observational registry carried out in tertiary European hospitals. Inclusion criteria were: symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist; absence of any sort of electrocardiographic tracing during episodes (including wearables and other single lead devices), and having undergone an electrophysiological study aimed at the diagnosis of paroxysmal supraventricular tachycardia.

Recruitment information / eligibility
Status Completed
Enrollment 711
Est. completion date June 1, 2022
Est. primary completion date November 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist - Absence of any sort of ECG tracing during episodes (including wearables and other single lead devices) Exclusion criteria: - Documentation of preexcitation - Prior electrophysiological study aimed at the assessment of ventriculo-atrial conduction or induction of supraventricular tachycardias.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Electrophysiological study (and ablation when appropriate)
Electrophysiological study (and ablation when appropriate)

Locations
Country Name City State
Spain Hospital Universitario 12 de Octubre Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electrophysiological study findings Number of participants in whom paroxysmal supraventricular tachycardia or evidence of substrate enabling paroxysmal supraventricular tachycardia is observed in electrophysiological study 5 years
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