Supraventricular Tachycardia (SVT)NCT06622772
A Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia
A study testing Valsalva assist device and standard Valsalva manoeuvre in people with Supraventricular Tachycardia (SVT), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficiency of a device for terminating supraventricular tachycardia. The main questions it aims to answer are: The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia, but the success rate is low. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Supraventricular Tachycardia (SVT)
- What is being tested?
- Valsalva assist device and standard Valsalva manoeuvre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 May 2024
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient having supraventricular tachycardia (SVT) with regular, narrow complex tachy-arrythmia with a QRS duration \< 0.12 ms on ECG and eligible for treatment with the Valsalva manoeuvre.
- AVNRT (atrioventricular nodal re-entry tachycardia) or AVRT (atrioventricular re-entry tachycardia) conformed by electrophysiologic test.
Who cannot join
- Unable or unwilling to give informed verbal consent.
- SVT episode with hemodynamic instability (systolic blood pressure (BP) \< 90 mmHg).
- With atrial fibrillation or atrial flutter.
- Severe hypertension (systolic BP \&gt; 220 mmHg or diastolic BP \&gt; 120 mmHg).
- Contraindication or inability to perform a VM (aortic stenosis, recent myocardial infarction, glaucoma, retinopathy, recent eye surgery, paralysis).
- Third trimester pregnancy.
- Previous catheter ablation of SVT.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Evaluation of a Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia: a Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficiency of a device for terminating supraventricular tachycardia. The main questions it aims to answer are:
The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia, but the success rate is low. Can the device help to increase the sucess rate? Whether the device is effective and safe to use at home? Researchers will compare whether the device is more effective than a standard Valsalva manoeuvre to treat supraventricular tachycardia.
Participants will:
be randomly assigned (1:1) to a standard Valsalva manoeuvre group (control) or Valsalva manoeuvre with the device (intervention) .
Read the detailed description
- Quality control and quality assurance: Over the first month of the trial, clinical investigators will come off-line for active participation once all local regulatory requirements have been met. Training for Valsalva manoeuvre procedure, data collection and reporting must be completed. Endpoint and Adverse Event Committee will be installed comprising of medical experts who are not involved in the study.
Periodic monitoring visits will be made throughout the clinical study to assure that the Investigator obligations are fulfilled, and all applicable regulations and guidelines are being followed. Key variables (demographics, inclusion/exclusion criteria, and safety) on the CRFs will be compared with each subject's source documents. Any discrepancies will be noted and resolved.
The auditor will check potential problems, evaluating whether their study implementation, data collection and data analysis are in accordance with the protocol, Manual of procedure (MOP) and good clinical practice (GCP) guidelines. CRFs, source documents and other study files must be accessible at all study sites at the time of auditing and inspection during the course of the study and after the completion of the study.
- Sample size: To calculate the required sample size, we estimated that the standard Valsalva manoeuvre would cause cardioversion in 20% of patients with supraventricular tachycardia on the basis of local audit data and previous studies. In our pro-protocol study, 40 patients were included, and the conversion rate of Valsalva manoeuvre with device to supraventricular tachycardia was 50%. We powered our study to be able to detect at least a 20% absolute improvement with the modified Valsalva manoeuvre, using the available evidence and the minimum improvement we thought would effect a change in practice. We estimated that this difference would require 106 patients per group (assuming a two-tailed test of statistical significance with an α of 0·05 and power of 0·9), and a 12 months recruitment period in our center.
- Statistical Analysis: Participants were analysed according to intention to treat, and endpoints will be attributed to the treatment arm to which the patients were randomized, regardless of treatment crossover or post-randomization medical care. The statistical analysis will be carried out in accordance with the pre-designed. We compared binary outcomes (including the primary outcome and the secondary outcome) using mixed effects logistic regression with allocation group as a fixed effect and clinicians as a random effect.
- Conditions
- Supraventricular Tachycardia (SVT)
- Being tested
- Valsalva assist device, standard Valsalva manoeuvre
- Keywords
- supraventricular tachycardia, Valsalva Manoeuvre
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva assist deviceDevice
A valsalva assist device designed to provide the recommended resistance to exhalation at a pressure of 40 mmHg.
standard Valsalva manoeuvreOther
The Valsalva manoeuvre is carried out without any device.
| Study group | Role | What they receive |
|---|---|---|
| VAD group | Experimental | Valsalva manoeuvre with a valsalva assist device (VAD) Receives: Device: Valsalva assist device |
| Control group | Other | standard Valsalva manoeuvre Receives: Other: standard Valsalva manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of sinus rhythm
The primary outcome is the presence of sinus rhythm as recorded by the treating clinician 1 min after twice VM and confirmed by ECG in the intention-to-treat population.
Measured: From enrollment to the end of treatment at 1 day.
Secondary outcomes (1)
The presence of sinus rhythm
Secondary outcomes are the presence of sinus rhythm as recorded by the treating clinician 1 min after once VM, and adverse events.
Measured: From enrollment to the end of treatment at 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 May 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 Supraventricular Tachycardia (SVT)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songnan Li, Beijing Anzhen Hospital
- Investigators
- Songnan Li, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622772
- Sponsor's protocol ID
- KS2023109
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD.
Publications
Huang L, Sang C, Gao M, Lai Y, Zhang J, Wang Y, Guo L, Liu N, Liu X, Guo X, Guo Q, Zuo S, Li C, Jiang C, Zhao Z, Tang R, Li S, Long D, Du X, Dong J, Ma C, Macle L. Device-Assisted vs Standard Valsalva Maneuver for Terminating Supraventricular Tachycardia: A Randomized Clinical Trial. JAMA Cardiol. 2026 Mar 1;11(3):304-307. doi: 10.1001/jamacardio.2025.5489.
PubMed 41670992
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06622772
- Acronym / sponsor ID
- KS2023109
- Conditions
- Supraventricular Tachycardia (SVT)
- Keywords
- supraventricular tachycardia, Valsalva Manoeuvre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Oct 2024 (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.
The goal of this clinical trial is to evaluate the efficiency of a device for terminating supraventricular tachycardia. The main questions it aims to answer are:
The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia, but the success rate is low. Can the device help to increase the sucess rate? Whether the device is effective and safe to use at home? Researchers will compare whether the device is more effective than a standard Valsalva manoeuvre to treat supraventricular tachycardia.
Participants will:
be randomly assigned (1:1) to a standard Valsalva manoeuvre group (control) or Valsalva manoeuvre with the device (intervention) .
Detailed description
- Quality control and quality assurance: Over the first month of the trial, clinical investigators will come off-line for active participation once all local regulatory requirements have been met. Training for Valsalva manoeuvre procedure, data collection and reporting must be completed. Endpoint and Adverse Event Committee will be installed comprising of medical experts who are not involved in the study.
Periodic monitoring visits will be made throughout the clinical study to assure that the Investigator obligations are fulfilled, and all applicable regulations and guidelines are being followed. Key variables (demographics, inclusion/exclusion criteria, and safety) on the CRFs will be compared with each subject's source documents. Any discrepancies will be noted and resolved.
The auditor will check potential problems, evaluating whether their study implementation, data collection and data analysis are in accordance with the protocol, Manual of procedure (MOP) and good clinical practice (GCP) guidelines. CRFs, source documents and other study files must be accessible at all study sites at the time of auditing and inspection during the course of the study and after the completion of the study.
- Sample size: To calculate the required sample size, we estimated that the standard Valsalva manoeuvre would cause cardioversion in 20% of patients with supraventricular tachycardia on the basis of local audit data and previous studies. In our pro-protocol study, 40 patients were included, and the conversion rate of Valsalva manoeuvre with device to supraventricular tachycardia was 50%. We powered our study to be able to detect at least a 20% absolute improvement with the modified Valsalva manoeuvre, using the available evidence and the minimum improvement we thought would effect a change in practice. We estimated that this difference would require 106 patients per group (assuming a two-tailed test of statistical significance with an α of 0·05 and power of 0·9), and a 12 months recruitment period in our center.
- Statistical Analysis: Participants were analysed according to intention to treat, and endpoints will be attributed to the treatment arm to which the patients were randomized, regardless of treatment crossover or post-randomization medical care. The statistical analysis will be carried out in accordance with the pre-designed. We compared binary outcomes (including the primary outcome and the secondary outcome) using mixed effects logistic regression with allocation group as a fixed effect and clinicians as a random effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAD group | Experimental | Device: Valsalva assist deviceValsalva manoeuvre with a valsalva assist device (VAD) |
| Control group | Other | Other: standard Valsalva manoeuvrestandard Valsalva manoeuvre |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient having supraventricular tachycardia (SVT) with regular, narrow complex tachy-arrythmia with a QRS duration \< 0.12 ms on ECG and eligible for treatment with the Valsalva manoeuvre.
- AVNRT (atrioventricular nodal re-entry tachycardia) or AVRT (atrioventricular re-entry tachycardia) conformed by electrophysiologic test.
Key exclusion criteria (7 listed)
- Unable or unwilling to give informed verbal consent.
- SVT episode with hemodynamic instability (systolic blood pressure (BP) \< 90 mmHg).
- With atrial fibrillation or atrial flutter.
- Severe hypertension (systolic BP \&gt; 220 mmHg or diastolic BP \&gt; 120 mmHg).
- Contraindication or inability to perform a VM (aortic stenosis, recent myocardial infarction, glaucoma, retinopathy, recent eye surgery, paralysis).
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 |
|---|---|---|
| Valsalva assist deviceA valsalva assist device designed to provide the recommended resistance to exhalation at a pressure of 40 mmHg. | Device | VAD group |
| standard Valsalva manoeuvreThe Valsalva manoeuvre is carried out without any device. | Other | Control group |
Primary outcome
The presence of sinus rhythm
Time frame: From enrollment to the end of treatment at 1 day.
The primary outcome is the presence of sinus rhythm as recorded by the treating clinician 1 min after twice VM and confirmed by ECG in the intention-to-treat population.
1 secondary outcome
The presence of sinus rhythm
Time frame: From enrollment to the end of treatment at 1day
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 2 Oct 2024.
- Derived from this study: PubMed 41670992Huang L, Sang C, Gao M, Lai Y, Zhang J, Wang Y, Guo L, Liu N, Liu X, Guo X, Guo Q, Zuo S, Li C, Jiang C, Zhao Z, Tang R, Li S, Long D, Du X, Dong J, Ma C, Macle L. Device-Assisted vs Standard Valsalva Maneuver for Terminating Supraventricular Tachycardia: A Randomized Clinical Trial. JAMA Cardiol. 2026 Mar 1;11(3):304-307. doi: 10.1001/jamacardio.2025.5489.
- Individual participant dataSharing planned: Yes. All collected IPD.
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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.
Songnan Li principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva assist device and standard Valsalva manoeuvre in people with Supraventricular Tachycardia (SVT), run by Beijing Anzhen Hospital at 1 site in China.
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 7 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 2 Oct 2024. 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 China. 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?
The presence of sinus rhythm (time frame: From enrollment to the end of treatment at 1 day.). 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 NCT06622772, 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 2 Oct 2024.