Skip to content

Investigator-initiated clinical trial of bradycardia with transvenous vagus nerve stimulation catheters for supraventricular tachyarrhythmias

Investigator-initiated clinical trial to investigate the safety and efficacy of intravenous vagal nerve stimulation catheter for bradycardia in patients with supraventricular tachyarrhythmia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2072230062
Enrollment
20
Registered
2023-09-12
Start date
2024-03-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation/Atrial flutter/Atrial tachycardia etc.

Interventions

Intravenous vagal nerve stimulation catheter

Sponsors

Sakamoto Kazuo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 years or older at the time of obtaining consent 2) Patients with supraventricular tachyarrhythmia who undergo catheter ablation 3) Patients who have been fully informed, understood and given free written consent by the investigator or sub-investigator of the study 4) Patients with no cardiac dysfunction (left ventricular ejection fraction more than 50%) at level 1-1

Exclusion criteria

Exclusion criteria: 1) Patients with anomaly of the superior vena cava 2) Patients with uncontrolled gastric and duodenal ulcers 3) Patients with implanted pacemaker (including leadless pacemaker), ICD (including S-ICD) and CRT 4) Patients with a temporary pacemaker inserted 5) Patients with contraindications to contrast media or severe allergy to contrast media 6) Patients with any kind of metal allergy 7) Patients with active bleeding 8) Patients with NYHA class IV 9) Patients with severe haemodynamic compromise, such as cardiogenic shock 10) Patients who are pregnant or potentially pregnant, or who wish to become pregnant during participation in the study 11) Patients participating in another clinical trial within 3 months of treatment 12) Patients who are judged by the investigator or sub-investigator to be unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in mean heart rate before and after stimulation

Secondary

MeasureTime frame
Change in heart rate after stimulation Percentage of target heart rate achieved Hemodynamics changes Clinical heart failure indicators Number of adverse events Number of failures

Contacts

Public ContactEiko Ishida

Kyushu University Hospital

ishida.eiko.504@m.kyushu-u.ac.jp+81-92-642-6291

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026