Supraventricular TachycardiaBELIEVE-SVTNCT06046352
Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia
An observational study of Supraventricular Tachycardia, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Electrophysiological study (and ablation when appropriate)
- Type of treatment
- Surgery or procedure
- How many people
- 711 participants
- Where
- 1 siteSpain
- Study dates
- 17 Dec 2019to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with palpitations clinically suggestive of paroxysmal supraventricular tachycardia but no ECG documentation of tachycardia
Who may be able to join
- 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)
Who cannot join
- Documentation of preexcitation
- Prior electrophysiological study aimed at the assessment of ventriculo-atrial conduction or induction of supraventricular tachycardias.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Electrophysiological study (and ablation when appropriate)
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological study (and ablation when appropriate)Procedure or surgery
Electrophysiological study (and ablation when appropriate)
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Non-documented, clinically-suspected PSVT Receives: Procedure: Electrophysiological study (and ablation when appropriate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological study findings
Number of participants in whom paroxysmal supraventricular tachycardia or evidence of substrate enabling paroxysmal supraventricular tachycardia is observed in electrophysiological study
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Dec 2019
- Primary completion2 Nov 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rodriguez, MD PhD, Principal investigator, University Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046352
- Sponsor's protocol ID
- 19/562
- Acronym
- BELIEVE-SVT
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden Guiding Invasive Electrophysiological Study in Paroxysmal Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06046352
- Acronym / sponsor ID
- BELIEVE-SVT / 19/562
- Conditions
- Supraventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: Electrophysiological study (and ablation when appropriate)Non-documented, clinically-suspected PSVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with palpitations clinically suggestive of paroxysmal supraventricular tachycardia but no ECG documentation of tachycardia
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Documentation of preexcitation
- Prior electrophysiological study aimed at the assessment of ventriculo-atrial conduction or induction of supraventricular tachycardias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological study (and ablation when appropriate)Electrophysiological study (and ablation when appropriate) | Procedure or surgery | Cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rodriguez, MD PhD principal investigator
University Hospital 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Tachycardia, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological study findings (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.