Study Stopped
Study was halted to make device updates
Proof of Concept Study for 1 Lead Patch Technology
1 other identifier
interventional
1
1 country
1
Brief Summary
This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2014
CompletedFirst Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2016
CompletedResults Posted
Study results publicly available
April 6, 2018
CompletedApril 6, 2018
March 1, 2018
2.2 years
August 25, 2015
March 7, 2018
April 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Outcome Measure - 100% Successful ECG Acquisition
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
Between 7 and 14 days
Secondary Outcomes (1)
Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch
Between 7 and 14 days
Study Arms (1)
1-Lead Outpatient Telemetry
EXPERIMENTAL1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.
Interventions
The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
Eligibility Criteria
You may qualify if:
- Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
- Be recently prescribed a LifeWatch 3 Lead ACT monitor
You may not qualify if:
- under 21-years old
- pregnant or who may become become pregnant during the investigation period
- using internal or external defibrillators
- who are using pacemakers or implantable loop recorders
- showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
- meeting any contraindications for a patch biosensor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mt. Sinai Medical Center
New York, New York, 10029, United States
Results Point of Contact
- Title
- Paul Hanneman
- Organization
- LifeWatch Services, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Reddy, MD FACC FHRS
Mt. Sinai Medical Center
- PRINCIPAL INVESTIGATOR
Marie Noelle-Langan, MD
Mt. Sinai Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2015
First Posted
August 26, 2015
Study Start
April 16, 2014
Primary Completion
June 9, 2016
Study Completion
June 9, 2016
Last Updated
April 6, 2018
Results First Posted
April 6, 2018
Record last verified: 2018-03