Arrhythmias, Cardiac Clinical Trial
Official title:
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
NCT number | NCT04556240 |
Other study ID # | TP-323 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2020 |
Est. completion date | November 30, 2020 |
Verified date | July 2023 |
Source | VitalConnect Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years or older; 2. If recommended mobile cardiac telemetry (MCT) by the care provider 3. If instructed, be willing to record information such as daily activities and symptoms 4. Able to speak, read, and write English. Exclusion Criteria: 1. Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites; 2. Have a known allergy to medical adhesives; 3. Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study. |
Country | Name | City | State |
---|---|---|---|
United States | Site 1 | Chevy Chase | Maryland |
Lead Sponsor | Collaborator |
---|---|
VitalConnect Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit | Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject | Each patient will be monitored for up-to 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03079726 -
Use of Device Data to Predict Frailty in Individuals
|
||
Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT05404789 -
Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia
|
N/A | |
Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
Recruiting |
NCT04471584 -
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
|
N/A | |
Recruiting |
NCT02906189 -
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
|
N/A | |
Completed |
NCT02550340 -
Munich Study for Beer Related ECG Change Workup
|
N/A | |
Completed |
NCT02466633 -
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
|
N/A | |
Completed |
NCT01871090 -
Remote Device Interrogation In The Emergency Department
|
N/A | |
Completed |
NCT04884100 -
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
|
N/A | |
Active, not recruiting |
NCT05481359 -
AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
|
||
Recruiting |
NCT05047835 -
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
|
||
Not yet recruiting |
NCT05957315 -
Mobile Cardiac Outpatient Telemetry for Unexplained Syncope
|
N/A | |
Not yet recruiting |
NCT05974306 -
Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System
|
N/A | |
Completed |
NCT06260670 -
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
|
N/A | |
Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
Completed |
NCT04943354 -
Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure
|
N/A | |
Recruiting |
NCT03857711 -
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
|
N/A | |
Recruiting |
NCT04869527 -
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
|