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

• Sponsor: Hospital Universitario 12 de Octubre (Other)
• Overall Status: Completed
• CT.gov ID: NCT06046352
• Collaborator: (none)
• Enrollment: 711
• Location: 1
• Actual Duration (Months): 29.5
• Patients Per Site Per Month: 24.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Supraventricular Tachycardia	Procedure: Electrophysiological study (and ablation when appropriate)

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 Design

• Study Type: Observational
• Actual Enrollment: 711 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia
• Actual Study Start Date: Dec 17, 2019
• Actual Primary Completion Date: Nov 2, 2021
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Electrophysiological study findings [5 years]

   Number of participants in whom paroxysmal supraventricular tachycardia or evidence of substrate enabling paroxysmal supraventricular tachycardia is observed in electrophysiological study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario 12 de Octubre	Madrid		Spain	28041

Sponsors and Collaborators

• Hospital Universitario 12 de Octubre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitario 12 de Octubre
• ClinicalTrials.gov Identifier: NCT06046352
• Other Study ID Numbers: 19/562
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Supraventricular; Tachycardia, Ventricular

Study Results

No Results Posted as of Sep 21, 2023