Tachycardia, SupraventricularINFLICTNCT06077799
prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia
An observational study of Tachycardia, Supraventricular, run by Azienda Usl di Bologna at 3 sites in Italy.
Trial summary
Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Supraventricular
- How many people
- 1,234 participants
- Where
- 3 sitesItaly
- Study dates
- 14 Jun 2023to 31 Oct 2024
- 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 affected by any form of supraventricular tachycardia
Who may be able to join
- patients accepting to participate
- patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service
Who cannot join
- not willing to participate, not able to give consent
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Unità Sanitaria Locale
Bologna, Bologna, 40100
Agenzia Regionale Emergenza Urgenza (AREU), Dipartimento di Emergenza e Accettazione, ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Universitaria Maggiore della Carità, Novara, Italy
Novara, Italy
About this study
Official title: prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare
Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.
Read the detailed description
Supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.This study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.
- Conditions
- Tachycardia, Supraventricular
- Keywords
- supraventricular tachycardia
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| supraventricular tachycardia treated with intra-venous adenosine | supraventricular tachycardia treated with intra-venous adenosine | |
| supraventricular tachycardia treated with electrical synchronised cardioversion | supraventricular tachycardia treated with electrical synchronised cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT
absolute numbers and relative percentages of successful prehospital cardioversions obtained with the two techniques
Measured: Prehospital EMS assistance time
Secondary outcomes (2)
diagnostic accuracy for supraventricular tachycardia of the emergency medical service personnel
Sensitivity for PSVT of the EMS personnel
Measured: Prehospital EMS assistance time
adverse events
incidence of predefined serious adverse events (SAE) between the two groups
Measured: Prehospital EMS assistance time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start14 Jun 2023
- Primary completion31 Jan 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, SupraventricularStudies 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
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Azienda Regionale Emergenza Urgenza - AREU Lombardia, Azienda Ospedaliero Universitaria Maggiore della Carita
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077799
- Sponsor's protocol ID
- 296-2023-OSS-AUSLBO
- Acronym
- INFLICT
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamberini L, Carinci V, Pallavicini P, Rovera M, Tartaglione M, Gioachin R, D'ambrosio A, Fiameni R, Baroncini S, Allegri D, Coniglio C, Semeraro F, Ristagno G; INFLICT working group. Prehospital management of supraventricular tachycardia: a multicentre study of current practices with a subgroup propensity score-based comparison of adenosine and electrical cardioversion in unstable patients. Resuscitation. 2025 Oct;215:110707. doi: 10.1016/j.resuscitation.2025.110707. Epub 2025 Jul 7.
PubMed 40633750
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare
- ClinicalTrials.gov ID
- NCT06077799
- Acronym / sponsor ID
- INFLICT / 296-2023-OSS-AUSLBO
- Conditions
- Tachycardia, Supraventricular
- Keywords
- supraventricular tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Azienda Regionale Emergenza Urgenza - AREU Lombardia, Azienda Ospedaliero Universitaria Maggiore della Carita
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Oct 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.
Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.
Detailed description
Supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.This study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraventricular tachycardia treated with intra-venous adenosine | – | –supraventricular tachycardia treated with intra-venous adenosine |
| supraventricular tachycardia treated with electrical synchronised cardioversion | – | –supraventricular tachycardia treated with electrical synchronised cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients affected by any form of supraventricular tachycardia
Key inclusion criteria (2 listed)
- patients accepting to participate
- patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service
Key exclusion criteria (1 listed)
- not willing to participate, not able to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT
Time frame: Prehospital EMS assistance time
absolute numbers and relative percentages of successful prehospital cardioversions obtained with the two techniques
2 secondary outcomes
diagnostic accuracy for supraventricular tachycardia of the emergency medical service personnel
Time frame: Prehospital EMS assistance time
adverse events
Time frame: Prehospital EMS assistance time
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 13 Apr 2025.
- Derived from this study: PubMed 40633750Gamberini L, Carinci V, Pallavicini P, Rovera M, Tartaglione M, Gioachin R, D'ambrosio A, Fiameni R, Baroncini S, Allegri D, Coniglio C, Semeraro F, Ristagno G; INFLICT working group. Prehospital management of supraventricular tachycardia: a multicentre study of current practices with a subgroup propensity score-based comparison of adenosine and electrical cardioversion in unstable patients. Resuscitation. 2025 Oct;215:110707. doi: 10.1016/j.resuscitation.2025.110707. Epub 2025 Jul 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, Supraventricular, run by Azienda Usl di Bologna at 3 sites in Italy.
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 1 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT (time frame: Prehospital EMS assistance time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077799, which also lists 1 linked publication.
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 13 Apr 2025.