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Paroxysmal Supraventricular Tachycardia (PSVT)RVM-MVMNCT07785466

Comparing Two Vagal Maneuvers for Paroxysmal Supraventricular Tachycardia

A study testing Modified Valsalva Maneuver and Reverse Vagal Maneuver in people with Paroxysmal Supraventricular Tachycardia (PSVT), run by Salih Karakoyun at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare two physical techniques for treating paroxysmal supraventricular tachycardia in adults. This condition causes a fast, regular heartbeat that starts and stops suddenly. Participants must be medically stable and have the condition confirmed by an electrocardiogram (ECG). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Modified Valsalva Maneuver and Reverse Vagal Maneuver
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 1 Aug 2026
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Presentation to the emergency department with symptoms consistent with paroxysmal supraventricular tachycardia (PSVT)
  • Electrocardiogram-confirmed PSVT, defined as a regular narrow-complex tachycardia with a heart rate of 135 to 250 beats per minute and no clearly visible P waves
  • Hemodynamically stable at enrollment, as determined by the treating emergency physician
  • No acute antiarrhythmic medication received for the index episode before enrollment
  • No electrical therapy received for the index episode before enrollment

Who cannot join

  • Systolic blood pressure below 90 mm Hg
  • Shock
  • Evidence of hypoperfusion
  • Altered mental status attributable to tachycardia
  • Ischemic chest discomfort attributable to tachycardia
  • Syncope attributable to tachycardia
Show all 22Show fewer
  • Acute heart failure attributable to tachycardia
  • Pulmonary edema attributable to tachycardia
  • Need for immediate cardioversion
  • Need for another urgent treatment
  • Inability to perform a vagal maneuver
  • Pregnancy
  • Body weight greater than 130 kg
  • Comorbidity making performance of a vagal maneuver unsafe
  • Previous operation making performance of a vagal maneuver unsafe
  • Prior familiarity with either study maneuver together with the ability to self-perform it
  • Reported acute use of a nonprescribed drug expected to affect heart rate or rhythm
  • Reported acute use of a stimulant expected to affect heart rate or rhythm
  • Reported acute exposure to another substance expected to affect heart rate or rhythm
  • Reported recent consumption of a food expected to affect heart rate or rhythm
  • Inability to provide informed consent
  • Spontaneous conversion to sinus rhythm before the study intervention

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine

    Düzce, 81620

Other trials in Turkey (Türkiye)

About this study

Official title: Reverse Vagal Maneuver Versus Modified Valsalva Maneuver for Paroxysmal Supraventricular Tachycardia: A Randomized Controlled Trial

The goal of this clinical trial is to compare two physical techniques for treating paroxysmal supraventricular tachycardia in adults. This condition causes a fast, regular heartbeat that starts and stops suddenly. Participants must be medically stable and have the condition confirmed by an electrocardiogram (ECG).

The main question is:

Read more

Does the reverse vagal maneuver restore normal heart rhythm more often than the modified Valsalva maneuver before rescue treatment is needed?

Researchers randomly assign participants to one of the two maneuvers.

Participants assigned to the modified Valsalva maneuver sit in a partly upright position. They blow into a 10-mL syringe for 15 seconds with enough force to move the plunger. They then lie flat while their legs are raised for 15 seconds.

Participants assigned to the reverse vagal maneuver sit upright and breathe out normally. They then close their nose and mouth and try to breathe in forcefully for 15 seconds.

All participants have an ECG before the maneuver and continuous heart rhythm monitoring. If normal rhythm is not restored, the assigned maneuver may be repeated up to three times. An ECG is recorded 45 seconds after each attempt. Participants receive standard rescue treatment if the assigned maneuver does not restore normal rhythm or if continuing becomes unsafe.

Researchers also record first-attempt success, rescue medication, electrical cardioversion, return of the fast heartbeat, hospital disposition, unwanted effects, repeat emergency department visits, and catheter ablation during one year of follow-up.

Being tested
Modified Valsalva Maneuver, Reverse Vagal Maneuver
Keywords
Paroxysmal supraventricular tachycardia, modified Valsalva maneuver, reverse vagal maneuver
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Valsalva ManeuverProcedure or surgery

    Participants were positioned semirecumbent with the stretcher head elevated to approximately 45° and instructed to blow into a 10-mL syringe for 15 seconds with sufficient force to move the plunger, aiming to generate approximately 40 mm Hg of expiratory pressure. Pressure was not measured using a manometer. Immediately afterward, participants were placed supine, and their legs were elevated to approximately 45°, without knee flexion, for 15 seconds. The maneuver could be repeated up to three times if sinus rhythm was not restored.

  • Reverse Vagal ManeuverProcedure or surgery

    Participants performed the maneuver while seated. After exhaling normally without force, they occluded the nose and mouth and attempted forceful inspiration against the closed airway for 15 seconds. The supervising clinician verified airway occlusion and completion of the prescribed sequence and duration. The maneuver could be repeated up to three times if sinus rhythm was not restored.

Study groups in NCT07785466
Study groupRoleWhat they receive
Reverse Vagal ManeuverExperimentalReverse vagal maneuver. Seated participants exhaled normally without force, occluded the nose and mouth, and attempted forceful inspiration against the closed airway for 15 seconds. The supervising clinician verified airway occlusion and completion of the prescribed sequence and duration .
Receives: Procedure: Reverse Vagal Maneuver
Modified Valsalva ManeuverActive comparatorModified Valsalva maneuver. Participants were positioned semirecumbent with the stretcher head elevated approximately 45° and instructed to blow into a 10-mL syringe for 15 seconds with sufficient force to move the plunger, aiming to generate approximately 40 mm Hg of expiratory pressure. Pressure was not measured by manometer. Immediately afterward, participants were placed supine and their legs were elevated to approximately 45°, without knee flexion, for 15 seconds.
Receives: Procedure: Modified Valsalva Maneuver

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol

    The primary outcome was ECG-confirmed conversion from PSVT to sinus rhythm following any of up to three permitted attempts of the assigned vagal maneuver and before initiation of rescue medication or electrical cardioversion. Conversion was determined using the standardized ECG assessment performed 45 seconds after completion of each attempt. Participants who remained in PSVT after completion or early discontinuation of the assigned maneuver protocol were classified as non-converters.

    Measured: At 45 seconds after the final performed assigned maneuver attempt, upon completion or early discontinuation of the protocol (maximum of 3 attempts) and before initiation of rescue therapy

Secondary outcomes (8)
  1. Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm

    Conversion was categorized as occurring after the first, second, or third assigned maneuver attempt, or as no conversion, based on ECG assessment 45 seconds after each attempt.

    Measured: At 45 seconds after each assigned maneuver attempt (attempts 1, 2, and 3), through completion of the assigned maneuver protocol and before initiation of rescue therapy

  2. Number of Participants Receiving Rescue Medication During the Index Emergency Department Visit

    Number of participants who received pharmacologic rescue treatment for persistent PSVT after failure or early discontinuation of the assigned maneuver protocol, or for recurrent PSVT after ECG-confirmed initial conversion during emergency department observation. Each participant was counted once, regardless of the number or type of rescue medications administered.

    Measured: From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours)

  3. Number of Participants Undergoing Electrical Cardioversion During the Index Emergency Department Visit

    Number of participants who underwent electrical cardioversion for persistent or recurrent PSVT during the index emergency department visit. Electrical cardioversion could be performed after failure or early discontinuation of the assigned maneuver protocol, or earlier if clinically indicated because of hemodynamic instability, clinical deterioration, intolerable symptoms, or concern that another assigned maneuver attempt was unsafe. Each participant was counted once, regardless of the number of cardioversion attempts performed.

    Measured: From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours).

  4. Number of Participants With Recurrent PSVT During Emergency Department Observation

    Number of randomized participants who experienced recurrence of PSVT after an initially successful ECG-confirmed conversion to sinus rhythm and before emergency department discharge or transfer to inpatient care during the index visit. Each participant was counted once, regardless of the number of recurrent PSVT episodes.

    Measured: From the initial ECG-confirmed conversion to sinus rhythm until emergency department discharge or transfer to inpatient care, whichever occurred first, assessed over an estimated period of 4 hours during the index visit.

  5. Number of Participants in Each Emergency Department Disposition Category at the End of the Index Visit

    Number of participants in each of three mutually exclusive emergency department disposition categories: discharge from the emergency department, admission to a hospital ward, or admission to an intensive care unit. Each participant was classified in one disposition category at the end of the index emergency department visit.

    Measured: At the end of the index emergency department visit, defined as emergency department discharge or transfer to a hospital ward or intensive care unit, assessed approximately 4 hours after randomization.

  6. Repeat Emergency Department Presentation for PSVT

    Repeat emergency department presentation for PSVT during follow-up.

    Measured: Up to 1 year after randomization

  7. Catheter Ablation During Follow-up

    Catheter ablation performed for PSVT after the index emergency department visit.

    Measured: Up to 1 year after randomization

  8. Participants Experiencing Any Prespecified Adverse Event

    This composite binary outcome indicated whether a participant experienced at least one prespecified adverse event during the assigned maneuver protocol or subsequent emergency department observation. Prespecified events included dizziness, nausea, dyspnea, presyncope, syncope, chest pain, hypotension, worsening arrhythmia, and other clinically important maneuver-related events. Each participant was counted once, regardless of the number or type of events experienced, and the outcome was reported as the number of participants with at least one event.

    Measured: From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start1 Mar 2024
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2026

Resources

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
Model description
This was a single-center, two-arm, parallel-group randomized controlled superiority trial. Hemodynamically stable adults with electrocardiogram-confirmed paroxysmal supraventricular tachycardia were randomly assigned in a 1:1 ratio to either the reverse vagal maneuver or the modified Valsalva maneuver. An independent researcher generated a computer-based permuted-block randomization sequence with variable block sizes. Allocation was concealed in sequentially numbered, opaque, sealed envelopes. Participants received only their assigned maneuver, which could be repeated up to three times if sinus rhythm was not restored. No crossover to the alternative maneuver was planned before rescue treatment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07785466
Sponsor's protocol ID
DU-RVM-MVM-PSVT-2023-04
Acronym
RVM-MVM
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data supporting the findings of this study will be available from the corresponding author upon reasonable request, subject to applicable ethical and institutional data-sharing requirements.

Publications

  • Corbacioglu SK, Akinci E, Cevik Y, Aytar H, Oncul MV, Akkan S, Uzunosmanoglu H. Comparing the success rates of standard and modified Valsalva maneuvers to terminate PSVT: A randomized controlled trial. Am J Emerg Med. 2017 Nov;35(11):1662-1665. doi: 10.1016/j.ajem.2017.05.034. Epub 2017 May 22.

    PubMed 28552271
  • Appelboam A, Reuben A, Mann C, Gagg J, Ewings P, Barton A, Lobban T, Dayer M, Vickery J, Benger J; REVERT trial collaborators. Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial. Lancet. 2015 Oct 31;386(10005):1747-53. doi: 10.1016/S0140-6736(15)61485-4. Epub 2015 Aug 24.

    PubMed 26314489
  • Gaudart P, Cazes N, Simon K, Larger D, Deharo JC. The reverse vagal manoeuvre: A new tool for treatment of supraventricular tachycardia? Am J Emerg Med. 2021 Mar;41:66-69. doi: 10.1016/j.ajem.2020.12.061. Epub 2020 Dec 26.

    PubMed 33387931

Questions about this trial

What is this clinical trial studying?

A study testing Modified Valsalva Maneuver and Reverse Vagal Maneuver in people with Paroxysmal Supraventricular Tachycardia (PSVT), run by Salih Karakoyun at 1 site in Turkey (Türkiye).

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 6 inclusion and 22 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 25 Aug 2026. 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 Turkey (Türkiye). 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?

ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol (time frame: At 45 seconds after the final performed assigned maneuver attempt, upon completion or early discontinuation of the protocol (maximum of 3 attempts) and before initiation of rescue therapy). 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 NCT07785466, which also lists 3 linked publications.

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 25 Aug 2026.

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