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Supraventricular TachycardiaNASVAL-SVTNCT07617077

NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia

A study testing Nasopharyngeal Swab Insertion and Modified Valsalva Maneuver (REVERT Protocol) in people with Supraventricular Tachycardia and Paroxysmal Supraventricular Tachycardia, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Supraventricular tachycardia (SVT) is a common heart rhythm disorder seen in emergency departments, causing a rapid heartbeat (typically 150-250 beats per minute). The current best non-drug treatment, the modified Valsalva maneuver (mVM), successfully restores normal rhythm in about 43% of cases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nasopharyngeal Swab Insertion and Modified Valsalva Maneuver (REVERT Protocol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Age 18 years or older
  • Electrocardiographically confirmed supraventricular tachycardia (SVT): narrow QRS complex (≤120 ms), regular rhythm, rapid ventricular rate, documented on 12-lead ECG or continuous cardiac monitoring
  • Hemodynamic stability, defined as ALL of the following simultaneously present:
  • Systolic blood pressure ≥90 mmHg
  • Diastolic blood pressure ≥60 mmHg
  • Alert and oriented mental status (GCS 15)
  • No signs of acute end-organ dysfunction
  • Ability and willingness to provide written informed consent

Who cannot join

  • Age younger than 18 years
  • Pregnancy (known or suspected)
  • Inability to confirm SVT diagnosis by ECG criteria
  • Delta wave or pre-excitation pattern on ECG (Wolff-Parkinson-White syndrome or asymptomatic pre-excitation) - due to risk of ventricular fibrillation with vagal maneuvers
  • Wide QRS tachycardia (QRS ≥120 ms) where ventricular tachycardia cannot be excluded
  • Absolute contraindication to modified Valsalva maneuver (inability to assume supine position or passive leg elevation)
Show all 10Show fewer
  • Contraindication to nasal swab (nasal surgery within 30 days, active epistaxis, visible nasal polyp or mass)
  • Hemodynamic instability requiring immediate synchronized cardioversion
  • Prior enrollment in this study (re-presentation with SVT)
  • Refusal to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University Pendik Training and Research Hospital

    Istanbul, Pendik, 34899

    Emir Ünal, 05327766010, emirunal@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized Controlled Trial Comparing Nasal Swab and Modified Valsalva Maneuver for the Treatment of Supraventricular Tachycardia

Supraventricular tachycardia (SVT) is a common heart rhythm disorder seen in emergency departments, causing a rapid heartbeat (typically 150-250 beats per minute). The current best non-drug treatment, the modified Valsalva maneuver (mVM), successfully restores normal rhythm in about 43% of cases. When these maneuvers fail, intravenous adenosine is used, which, while effective, can cause brief but distressing side effects such as chest tightness, shortness of breath, and intense anxiety.

During the COVID-19 pandemic, some patients briefly fainted during nasal swab collection. This happens because inserting a swab into the back of the nasal cavity (nasopharynx) stimulates the trigeminal nerve, which then activates the vagus nerve and slows the heart - a phenomenon called the trigeminocardiac (or nasocardiac) reflex. One published case report described a patient whose SVT was terminated within 10 seconds using a nasal swab.

Read more

This study compares the nasal swab technique with the modified Valsalva maneuver in patients presenting to the emergency department with SVT. Patients are randomly assigned to one of two groups. The primary outcome is whether a normal heart rhythm is restored within 1 minute of the procedure. Patient comfort and satisfaction are also measured.

The study is conducted in two phases. The first (pilot) phase (30 patients per group) will assess whether the study can be successfully conducted and collect data to finalize the required sample size. The second (main) phase will use the pilot phase's actual data to determine the final number of participants needed.

Read the detailed description

BACKGROUND:

Supraventricular tachycardia (SVT) encompasses re-entrant arrhythmias dependent on the atrioventricular node, including atrioventricular nodal re-entry tachycardia (AVNRT) and atrioventricular re-entry tachycardia (AVRT). Vagal maneuvers increase parasympathetic tone via the vagus nerve, slowing atrioventricular conduction and terminating these re-entrant circuits. The modified Valsalva maneuver (REVERT protocol) achieves termination in approximately 43% of cases, making it the most effective non-pharmacological approach currently available.

The trigeminocardiac reflex (TCR), also termed the nasocardiac reflex, involves mechanical stimulation of the nasal mucosa and nasopharynx activating the trigeminal nerve (V1/V2 branches) → pterygopalatine ganglion → trigeminal nucleus → dorsal vagal nucleus → cardiac inhibitory parasympathetic output → bradycardia. This reflex has been documented in nasoendoscopy studies (observed in approximately 30% of patients) and was reported to cause syncope during COVID-19 nasopharyngeal swab collection. Hooker and Liebman (2023) reported SVT termination within 10 seconds of nasal swab insertion in a patient refractory to other vagal maneuvers and adenosine. Cinpolat et al. (2025) reported a mean 28% decrease in heart rate and 22% decrease in systolic blood pressure during nasopharyngeal swab procedures, explicitly suggesting SVT as a potential application.

STUDY DESIGN:

Two-phase prospective single-center randomized controlled superiority trial.

  • Phase 1 (pilot): 30 participants per arm (n=60 total). Primary aim: feasibility assessment.
  • Phase 2 (main): Sample size recalculated from actual pilot-phase conversion rates.

RANDOMIZATION: Computer-generated blocked randomization (block sizes 4 and 6, randomly mixed) stratified by SVT subtype (probable AVNRT / probable AVRT / indeterminate). Allocation concealment using sequentially numbered, sealed, opaque envelopes.

BLINDING: Open-label for participants and care providers; outcome assessor (30-minute satisfaction survey) and statistician are blinded.

INTERVENTIONS:

  • Arm 1 (Nasal Swab): Standard nasopharyngeal swab inserted through the right nostril, parallel to the nasal septum, to the nasopharyngeal vault. Held for 10 seconds with gentle rotation, then withdrawn. Patient in 45-degree semi-recumbent position.
  • Arm 2 (mVM/REVERT): Forced expiration for 15 seconds into 10 mL syringe barrel, immediately followed by rapid supine repositioning and 45-degree passive leg elevation for 15 seconds.

OUTCOMES: Primary: sinus rhythm conversion at 1 minute (T=60 seconds post-procedure). Secondary: conversion at 3 and 5 minutes; rescue adenosine requirement; procedural discomfort (VAS 0-10); treatment satisfaction (5-point Likert); re-preference; SVT recurrence at 24 hours and 30 days; adverse event profile.

STATISTICAL ANALYSIS: Chi-square or Fisher's exact test for the primary outcome. Results reported as absolute risk difference with 95% CI. Intention-to-treat analysis as the primary; per-protocol analysis as a sensitivity analysis. Benjamini-Hochberg correction for secondary outcomes. Multiple imputation (MICE) for missing data between 5-20%.

SAFETY STOPPING RULES: Immediate procedure termination and rescue therapy for hemodynamic deterioration, arrhythmia worsening, patient request, or serious adverse event. Pilot phase safety stopping rule: ≥3 serious adverse events in either group triggers protocol review.

PILOT FEASIBILITY GO/NO-GO CRITERIA:

  • Monthly enrollment rate: ≥5 patients/month
  • Protocol adherence rate: ≥85%
  • Missing data rate: ≤10%
  • 30-day follow-up completion: ≥70%
Being tested
Nasopharyngeal Swab Insertion, Modified Valsalva Maneuver (REVERT Protocol)
Keywords
SVT, nasal swab, nasocardiac reflex, trigeminocardiac reflex, Valsalva maneuver, REVERT, emergency department
Medical subject headings
Tachycardia, Supraventricular, Tachycardia, Ventricular, Tachycardia, Atrioventricular Nodal Reentry, Emergencies

What participants receive

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

  • Nasopharyngeal Swab InsertionProcedure or surgery

    A standard nasopharyngeal swab (approximately 15 cm flexible nylon-tipped swab, sterile) is inserted through the right nostril (left if anatomically impeded), directed parallel to the nasal septum along the nasal floor (posteriorly, not superiorly), and advanced until mild resistance is felt at the nasopharyngeal vault. The swab is held in this position for 10 seconds with optional gentle rotation, then slowly withdrawn. The procedure is performed with the patient in a 45-degree semi-recumbent position under continuous cardiac monitoring (ECG, SpO2, NIBP). T=0 is defined as the moment the swab is fully withdrawn. The procedure is performed once; failure leads to rescue therapy (intravenous adenosine) without a second attempt.

  • Modified Valsalva Maneuver (REVERT Protocol)Procedure or surgery

    The modified Valsalva maneuver is performed per the REVERT protocol. The patient, seated at 45 degrees, performs a forced expiration for 15 seconds into the barrel of a 10 mL syringe (aiming to push the plunger back, targeting an expiratory pressure of≥40 mmHg). Immediately upon completion, the patient is rapidly repositioned supine, and both legs are passively elevated to 45 degrees for 15 seconds, then returned to the semi-recumbent position. Total maneuver duration is approximately 30 seconds. T=0 is defined as the moment the patient returns to the semi-recumbent position. The procedure is performed once; failure leads to rescue therapy (intravenous adenosine) without a second attempt.

Study groups in NCT07617077
Study groupRoleWhat they receive
Nasal Swab GroupExperimentalNasopharyngeal swab insertion per standardized protocol
Receives: Procedure: Nasopharyngeal Swab Insertion
Modified Valsalva GroupActive comparatorModified Valsalva maneuver per REVERT protocol
Receives: Procedure: Modified Valsalva Maneuver (REVERT Protocol)

What is being measured

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

  1. Sinus Rhythm Conversion Rate at 1 Minute

    Proportion of participants who convert to sinus rhythm within 1 minute of procedure completion (T=60 seconds), as assessed by continuous 12-lead ECG monitoring. T=0 is defined as the moment the intervention is completed (swab withdrawn / patient returned to semi-recumbent position after leg raise). Rhythm is independently verified by two investigators reviewing the ECG rhythm strip recording. Conversion is defined as a dichotomous outcome: yes (sinus rhythm confirmed at T=60 seconds) or no.

    Measured: 1 minute after procedure completion

Secondary outcomes (2)
  1. Sinus Rhythm Conversion Rate at 5 Minutes

    Proportion of participants who convert to sinus rhythm within 5 minutes of procedure completion, assessed by continuous ECG monitoring.

    Measured: 5 minutes after procedure completion

  2. Adverse Events Profile

    Incidence and nature of adverse events including but not limited to epistaxis, vasovagal syncope, significant bradycardia (heart rate <40 bpm), hypotension, and respiratory distress, documented on a structured adverse event checklist.

    Measured: During procedure and up to 30 minutes after procedure completion

Timeline

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

  1. First posted1 Jun 2026
  2. Study start1 May 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617077
Sponsor's protocol ID
09.2025.299
Acronym
NASVAL-SVT
Status last verified
May 2026
First submitted
23 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes, individual participant de-identified data (including the data dictionary and statistical analysis plan) will be shared. Data will be available beginning 12 months after primary publication to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author (emirunal@gmail.com).

Publications

  • Hooker EA, Liebman JS. Termination of paroxysmal supraventricular tachycardia by intranasal swab insertion. Am J Emerg Med. 2023 Oct;72:222.e3-222.e4. doi: 10.1016/j.ajem.2023.08.002. Epub 2023 Aug 2.

    PubMed 37543444
  • Koskinen A, Tolvi M, Jauhiainen M, Kekalainen E, Laulajainen-Hongisto A, Lamminmaki S. Complications of COVID-19 Nasopharyngeal Swab Test. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):672-674. doi: 10.1001/jamaoto.2021.0715.

    PubMed 33914064
  • Betlejewski S, Betlejewski A, Burduk D, Owczarek A. [Nasal-cardiac reflex]. Otolaryngol Pol. 2003;57(5):613-8. Polish.

    PubMed 14994602
  • Boux I, Tomasello R, Grisoni L, Pulvermuller F. Brain signatures predict communicative function of speech production in interaction. Cortex. 2021 Feb;135:127-145. doi: 10.1016/j.cortex.2020.11.008. Epub 2020 Dec 2.

    PubMed 33360757
  • Cinpolat R. Nasocardiac reflex-induced resolution of persistent hiccups via intranasal swab stimulation: A case report. Am J Emerg Med. 2025 Jun;92:253.e3-253.e4. doi: 10.1016/j.ajem.2025.04.003. Epub 2025 Apr 2.

    PubMed 40187990
  • Case LK, Madian N, McCall MV, Bradson ML, Liljencrantz J, Goldstein B, Alasha VJ, Zimmerman MS. Abeta-CT Affective Touch: Touch Pleasantness Ratings for Gentle Stroking and Deep Pressure Exhibit Dependence on A-Fibers. eNeuro. 2023 May 26;10(5):ENEURO.0504-22.2023. doi: 10.1523/ENEURO.0504-22.2023. Print 2023 May.

    PubMed 37169581
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Nasopharyngeal Swab Insertion and Modified Valsalva Maneuver (REVERT Protocol) in people with Supraventricular Tachycardia and Paroxysmal Supraventricular Tachycardia, run by Marmara University Pendik Training and Research Hospital 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Jun 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emir Ünal (+905327766010, emirunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sinus Rhythm Conversion Rate at 1 Minute (time frame: 1 minute after procedure completion). 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 NCT07617077, which also lists 7 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 1 Jun 2026.

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