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RecruitingNCT06229418RESTORe-CAREUpdated Oct 1, 2026

Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America

An interventional study of DFR AED Pilot Program in Cardiac Arrest and Sudden Cardiac Arrest, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Updated Oct 1, 2026Study completion movedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The overall goal of this project is to design, develop, and pilot test an emergency healthcare drone delivery system suitable for rural communities that can deliver AEDs to out-of-hospital cardiac arrest (OHCA) locations more rapidly than can be achieved with current first responder and EMS systems. The goal is to determine whether this method of AED delivery can be achieved rapidly enough to justify a future clinical trial directly testing its ability to improve OHCA survival.

Read the detailed description

To achieve the project goal, 3 specific aims will be addressed. The details in this ClinicalTrials.gov record are specific to Aim 3.

Aim 1:

Define options for emergency healthcare drone station configurations best suited for rural communities and use these findings to help design future drone AED delivery programs in rural communities.

Sub aim 1a:

Define and examine EMS agency treatment, performance, and outcomes of OCHA in rural versus urban regions across the US. This will be done by using CARES Registry data from all OHCA treated by emergency medical professionals from participating EMS agencies in the US between 2021-2022.

Sub aim 1b:

Develop an optimization model to examine the effectiveness of different options for placement of both public and drone-delivered AEDs in rural communities. This will be done by using CARES Registry data from OHCAs between 2012-2022 from participating EMS agencies in North Carolina.

Aim 2:

Develop procedural and operational infrastructure for drone AED delivery that can be applied to rural communities. The primary objective of this aim will be to demonstrate that drone AED delivery can be integrated effectively into existing FAA-approved drone-as-first responder programs.

Aim 3:

Pilot test the safety and effectiveness of emergency drone AED delivery models in 2 urban and 4 rural communities in Forsyth County, NC and James City County, VA.

Sub aim 3a:

Test the ability of the DRF-AED program to travel to the location of suspected OHCAs and arrive ahead of EMS. There will be 12-15 OHCAs across the 6 communities during this testing period.

Sub aim 3b:

Test the ability of the DRF-AED program to deliver and safely deploy AEDs (without interrupting bystanders) to sites of suspected OHCA. There will be 10-12 (with a maximum of 15) additional OCHAs across the 6 communities.

Sub aim 3c:

Test the ability of the DRF-AED program to deliver an AED and treat an OCHA patient suspected cardiac arrests. Up to 70 OHCAs are expected across all 6 communities.

Sub aim 3d:

Carry out simulated OHCA alerts and test the ability of the DRF-AED program to deliver AEDs to a simulated OCHA scene ahead of EMS or first responders. A minimum of 40 simulations of OHCA (10 per rural community) to occur.

02

Conditions studied

  • Cardiac Arrest
  • Sudden Cardiac Arrest

Keywords

  • Drone
  • Automated External Defibrillator
03

In context

Heart Arrest

926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 4 is below the median of 100 across 518 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Browse Duke University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients 18 years of age or older in the CARES registry who suffer cardiac arrest before arrival of a 911-responder of non-traumatic cause, including patients who receive an AED shock by a bystander prior to the arrival of 911 responders.

Exclusion criteria

Exclusion Criteria:

  • Patients in the CARES registry who have a traumatic cause of cardiac arrest.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    DFR AED Program

    Real-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban)

    Other: DFR AED Pilot Program

Interventions

  • OtherDFR AED Pilot Program

    Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs

06

What researchers measure

Primary outcomes

  1. Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene

    Time frame: 6 months (Aim 3a)

  2. Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene

    Time frame: 15 months (Aim 3c)

Secondary outcomes

  1. Proportion of OHCA cases with drone arrival ahead of EMS arrival

    Time frame: 6 months (Aim 3a)

  2. Proportion of OHCA cases with drone arrival ahead of EMS arrival

    Time frame: 15 months (Aim 3c)

  3. Proportion of times AED was successfully deployed

    Time frame: 6 months (Aim 3b)

  4. Time from drone arrival on scene to AED delivery on the ground

    Time frame: 6 months (Aim 3b)

  5. Drone altitude at time of deployment

    Time frame: 6 months (Aim 3b)

  6. Rates of bystander AED application

    Time frame: 15 months (Aim 3c)

  7. Proportions of initial shockable rhythm

    Time frame: 15 months (Aim 3c)

  8. Proportion of bystander defibrillation

    Time frame: 15 months (Aim 3c)

  9. Proportion of first responder defibrillation

    Time frame: 15 months (Aim 3c)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.

Of 204 non-industry interventional studies with no phase under Heart Arrest, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 18 months is below that.

Counting every sponsor, half of 218 studies reached it within 28 months; a quarter within 10 and three quarters within 47.

Completion moved once since we started tracking on Sep 25, 2026: Mar 2027 → Jun 2027, on Oct 1, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2024
First posted
Jan 29, 2024
StartActual
Sep 8, 2025
Primary completionEst.
Mar 31, 2027
CompletionEst.
Jun 30, 2027was Mar 2027
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Mar 31, 2027→Jun 30, 2027
Oct 1, 2026
Enrollment
128→4
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Study completion Mar 31, 2027→Jun 30, 2027
    Enrollment 128→4

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06229418
Lead sponsor
Duke University
Collaborators
Virginia Commonwealth University, University of Toronto, University of Washington
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Sep 8, 2025
Primary completion
Mar 31, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Leo Brothers, MPH
Contact
joseph.l.brothers@duke.edu
919-641-3555
Lauren Wilverding
Contact
lauren.wilverding@duke.edu
Monique Starks, MD
principal investigator · Duke University
Daniel Mark, MD
principal investigator · Duke University
Joseph Ornato, MD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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