NCT03657134 is a NA clinical trial of CoVa-2 Monitoring System in Atrial Fibrillation, sponsored by NYU Langone Health.

Who is sponsoring NCT03657134?

NCT03657134 is sponsored by NYU Langone Health.

What drugs are being tested in NCT03657134?

Interventions in NCT03657134: CoVa-2 Monitoring System.

What condition does NCT03657134 study?

NCT03657134 studies Atrial Fibrillation, Ventricular Tachycardia.

Is NCT03657134 still recruiting?

NCT03657134 is currently completed. Last updated 22 September 2021.

Are results published for NCT03657134?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-22 · How we verify

NCT03657134

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor

Completed NA Results posted Last updated 22 September 2021

What this trial tests

NA trial testing CoVa-2 Monitoring System in Atrial Fibrillation in 20 participants. Completed in 28 July 2020.

Timeline

15 November 2018

Primary endpoint
28 July 2020

28 July 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	15 November 2018
Primary completion	28 July 2020
Estimated completion	28 July 2020
Sites	1 location across United States

Drugs / interventions tested

CoVa-2 Monitoring System

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →
Ventricular Tachycardia — all drugs for Ventricular Tachycardia →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or Ventricular Tachycardia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Change in Heart Rate (HR) Primary · Baseline, 8 Hours

HR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in HR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.

Group	Value	95% CI
EP Procedure	6.5	± 0.3

Average Change in Respiratory Rate (RR) Primary · Baseline, 8 Hours

RR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in RR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.

Group	Value	95% CI
EP Procedure	3.8	± 0.8

Sponsor's own description

Subjects will be consented to wear the CoVa-2 monitoring system prior to (baseline), during, and after an Electrophysiology Procedure (EP). During this time, the system will measure the following parameters from subjects: heart rate (HR), Heart Rate Variability (HRV), respiration rate (RR), and Cardiac Output (CO). Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. Subjects will not be measured while transferred in and out of the operating room. Approximate sample size is 20 subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting

Other NYU Langone Health trials

Trials by the same sponsor.

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NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03657134 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 22 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03657134.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing