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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 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.

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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.

Conditions Studied

Atrial Fibrillation

Interventions

  • DEVICE Sham Device
  • DEVICE CardiaCare RR2

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2024-10-02
Est. Completion 2026-12
Phase NA

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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What the Registry Record Tells You About NCT06748157

The ClinicalTrials.gov registry entry for NCT06748157 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.