Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia (BELIEVE-SVT)

September 18, 2023 updated by: Hospital Universitario 12 de Octubre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

711

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with palpitations clinically suggestive of paroxysmal supraventricular tachycardia but no ECG documentation of tachycardia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Non-documented, clinically-suspected PSVT
Procedure: Electrophysiological study (and ablation when appropriate)
Electrophysiological study (and ablation when appropriate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological study findings
Time Frame: 5 years
Number of participants in whom paroxysmal supraventricular tachycardia or evidence of substrate enabling paroxysmal supraventricular tachycardia is observed in electrophysiological study
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Investigators

  • Principal Investigator: Daniel Rodriguez, MD PhD, University Hospital 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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