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NCT06748157 · ClinicalTrials.gov registry record · NA
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
A NA study of Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT06748157: Active NA study of Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06748157 is a NA study of Atrial Fibrillation that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 34 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06748157, a NA study of Atrial Fibrillation, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF. The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following: 1. early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period 2. AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label). The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
Primary Outcome
Burden of AF/AFL (defines as 30 seconds or longer) during the 2-months and 6-months period after ablation measured using ECG-patch monitoring and daily RR2 single lead ECG.
Conditions Studied
Interventions
- DEVICE Sham Device
- DEVICE CardiaCare RR2
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT06748157 still lists
NCT06748157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.
NCT06748157 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06748157 about?
NCT06748157 is a clinical study titled "Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation". Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergon...
What is the current status of trial NCT06748157?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2024-10-02. Estimated completion is 2026-12.
What conditions does trial NCT06748157 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT06748157?
The interventions under investigation include: Sham Device (DEVICE), CardiaCare RR2 (DEVICE).
Who is sponsoring clinical trial NCT06748157?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06748157 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06748157's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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