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

JRCT ID: jRCT2072230062

Registered date:12/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation/Atrial flutter/Atrial tachycardia etc.
• Date of first enrollment: 21/03/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Intravenous vagal nerve stimulation catheter

Outcome(s)

• Primary Outcome: Changes in mean heart rate before and after stimulation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Sakamoto Kazuo