Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Public ClinicalTrials.gov record NCT01486316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
Study identification
- NCT ID
- NCT01486316
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2011
- Primary completion
- Nov 30, 2014
- Completion
- Jan 31, 2015
- Last update posted
- Jul 11, 2018
2011 – 2015
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Green | La Jolla | California | 92037 | — |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Carolinas Medical Center/Sanger Heart & Vascular | Charlotte | North Carolina | 28203 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Lancaster Heart & Stroke Foundation | Lancaster | Pennsylvania | 17602 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| St. Thomas Research Institute | Nashville | Tennessee | 37205 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Heart Clinic PLLC | McAllen | Texas | 78503 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01486316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 11, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01486316 live on ClinicalTrials.gov.