VFPhase 1/2NCT07880873
Defibrio AED Study
A Phase 1/2 study testing treatment with Defibrio AED in people with VF and VT, run by Defibrio, LLC.
Trial summary
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator). The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to restore normal heart rhythm after an episode of VF (ventricular fibrillation) or VT… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- treatment with Defibrio AED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Weight > 25 kg
- BMI ≤ 45
- Able and willing to provide written informed consent before undergoing any study-related procedures
- Scheduled for any of the following procedures:
- Ablation of ventricular tachycardia or ventricular fibrillation
- Electrophysiology study for induction of ventricular arrhythmias
- Non-invasive electrophysiology testing using an existing implantable defibrillator
Who cannot join
- Any condition that in the physician investigator's opinion precludes the subject's ability to comply with the study requirements
- Pregnancy
- Use of any temporary or permanent mechanical circulatory support (e.g. LVAD, extracorporeal membrane oxygenation, intra-aortic balloon pump or Impella)
- Presence of a cardiac thrombus
- Atrial fibrillation or atrial flutter without therapeutic anticoagulation or left atrial appendage occlusion device with a leak
- Critical aortic stenosis
Show all 15Show fewer
- Unstable coronary artery disease (CAD)
- Stroke or transient ischemic attack (TIA) within past 90 days
- Hemodynamic instability
- Unstable angina
- New York Heart Association (NYHA) Class IV heart failure symptoms / ongoing inotrope support
- Left Ventricular Ejection Fraction (LVEF) < 20%
- History of inability to induce ventricular arrhythmias
- Active Do Not Resuscitate order
- Participation in any other clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Center, Prospective, Safety And Performance Evaluation Study On The Automated External Defibrillation Of Patients With VF/VT Using The Defibrio AED
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator).
The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to restore normal heart rhythm after an episode of VF (ventricular fibrillation) or VT (ventricular tachycardia).
Read more
The study will enroll 25 subjects in the United States. Participants that experience VF, or polymorphic VT, or pulseless VT, during an electrophysiology study or procedure will be treated with the Defibrio AED to restore normal heart rhythm.
Electrocardiography data will be collected from the clinical records, along with medical history, laboratory results, and medications information.
Read the detailed description
Title:
A multi-center, prospective, safety and performance evaluation study on the automated external defibrillation of patients with VF/VT using the Defibrio AED
Primary Objective:
To evaluate the ability of the Defibrio AED device to successfully deploy and terminate episode(s) of ventricular tachycardia/ventricular fibrillation.
Secondary Objective:
To evaluate the frequency and severity of device related adverse events.
Primary and Secondary Endpoints are listed under outcome measures.
Study Population:
Individuals at the age of majority or older (i.e., ≥18 years), weight of 25 kg or greater, and BMI ≤ 45, with a diagnosis of a cardiomyopathy, heart rhythm disorder, congenital heart disease or other underlying condition as defined in the inclusion criteria, who are undergoing VT ablation, non-invasive programmed stimulation, or electrophysiology study for ventricular tachycardia induction.
Enrollment:
Subject enrollment will consist of a total of 25 subjects at up to 6 clinical sites located in the United States, with 20 evaluable subjects that completed the protocol.
Inclusion and Exclusion criteria are listed under the Eligibility section.
A Data Safety Monitoring Board (DSMB) will independently monitor patient safety during the duration of the clinical study.
Study Intervention:
Participants scheduled for VT ablation/EP study per standard of care will be eligible to participate if they meet all inclusion criteria and no exclusion criteria. If during the procedure VT or VF are detected that warrant a defibrillation shock, patients will receive a transthoracic ventricular defibrillation rescue shock using the Defibrio AED (study procedure) to restore normal sinus rhythm.
The Defibrio AED will be used once during the procedure, for the first occurrence of VT or VF that requires external defibrillation.
A secondary approved external defibrillator will be ready, already connected to the patient with pads in anteroposterior position, to provide second-line therapy if needed.
Data Collection:
Data collection will be performed on electronic case report forms to collect the following information from the clinical record: Inclusion-Exclusion, Demographics, Vital Signs, Medical History, Concomitant Medications, Diagnostic Laboratory Tests and Imaging, episodic ECG, AED data capture, EP Lab Procedure, Adverse Events, Study Completion.
Study timeline:
- Screening for eligibility and informed consent (up to 3 months before the day of the scheduled clinical procedure)
- intervention (defibrillation using the Defibrio AED) on the day of the scheduled clinical procedure
- discharge data collection (on the day of discharge, usually within 3 days of the clinical procedure)
- follow up data collection (on the day of the clinical follow up visit, within one month of the discharge date)
- Being tested
- treatment with Defibrio AED
- Keywords
- AED, defibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with Defibrio AEDDevice
treatment with Defibrio AED to terminate VT/VF episode
| Study group | Role | What they receive |
|---|---|---|
| intervention single arm | Experimental | all subjects in the same intervention arm (treatment with Defibrio AED) Receives: Device: treatment with Defibrio AED |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent detection
Percent detection of true shockable events
Measured: end of study (within one year of first subject enrollment)
percent termination
Percent successful termination of VT/VF
Measured: end of study (within one year of first subject enrollment)
Secondary outcomes (1)
adverse events if any
Frequency and severity of adverse events as defined in the protocol
Measured: end of study (within one year of first subject enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm: 25 subjects in intervention arm. All will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defibrio, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880873
- Sponsor's protocol ID
- PRO-207-AED-01
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will be retained as confidential during the study
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Safety And Performance Evaluation Study On The Automated External Defibrillation Of Patients With VF/VT Using The Defibrio AED
- ClinicalTrials.gov ID
- NCT07880873
- Acronym / sponsor ID
- PRO-207-AED-01
- Keywords
- AED, defibrillation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Defibrio, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator).
The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to restore normal heart rhythm after an episode of VF (ventricular fibrillation) or VT (ventricular tachycardia).
The study will enroll 25 subjects in the United States. Participants that experience VF, or polymorphic VT, or pulseless VT, during an electrophysiology study or procedure will be treated with the Defibrio AED to restore normal heart rhythm.
Electrocardiography data will be collected from the clinical records, along with medical history, laboratory results, and medications information.
Detailed description
Title:
A multi-center, prospective, safety and performance evaluation study on the automated external defibrillation of patients with VF/VT using the Defibrio AED
Primary Objective:
To evaluate the ability of the Defibrio AED device to successfully deploy and terminate episode(s) of ventricular tachycardia/ventricular fibrillation.
Secondary Objective:
To evaluate the frequency and severity of device related adverse events.
Primary and Secondary Endpoints are listed under outcome measures.
Study Population:
Individuals at the age of majority or older (i.e., ≥18 years), weight of 25 kg or greater, and BMI ≤ 45, with a diagnosis of a cardiomyopathy, heart rhythm disorder, congenital heart disease or other underlying condition as defined in the inclusion criteria, who are undergoing VT ablation, non-invasive programmed stimulation, or electrophysiology study for ventricular tachycardia induction.
Enrollment:
Subject enrollment will consist of a total of 25 subjects at up to 6 clinical sites located in the United States, with 20 evaluable subjects that completed the protocol.
Inclusion and Exclusion criteria are listed under the Eligibility section.
A Data Safety Monitoring Board (DSMB) will independently monitor patient safety during the duration of the clinical study.
Study Intervention:
Participants scheduled for VT ablation/EP study per standard of care will be eligible to participate if they meet all inclusion criteria and no exclusion criteria. If during the procedure VT or VF are detected that warrant a defibrillation shock, patients will receive a transthoracic ventricular defibrillation rescue shock using the Defibrio AED (study procedure) to restore normal sinus rhythm.
The Defibrio AED will be used once during the procedure, for the first occurrence of VT or VF that requires external defibrillation.
A secondary approved external defibrillator will be ready, already connected to the patient with pads in anteroposterior position, to provide second-line therapy if needed.
Data Collection:
Data collection will be performed on electronic case report forms to collect the following information from the clinical record: Inclusion-Exclusion, Demographics, Vital Signs, Medical History, Concomitant Medications, Diagnostic Laboratory Tests and Imaging, episodic ECG, AED data capture, EP Lab Procedure, Adverse Events, Study Completion.
Study timeline:
- Screening for eligibility and informed consent (up to 3 months before the day of the scheduled clinical procedure)
- intervention (defibrillation using the Defibrio AED) on the day of the scheduled clinical procedure
- discharge data collection (on the day of discharge, usually within 3 days of the clinical procedure)
- follow up data collection (on the day of the clinical follow up visit, within one month of the discharge date)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm: 25 subjects in intervention arm. All will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| intervention single arm | Experimental | Device: treatment with Defibrio AEDall subjects in the same intervention arm (treatment with Defibrio AED) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Weight > 25 kg
- BMI ≤ 45
- Able and willing to provide written informed consent before undergoing any study-related procedures
- Scheduled for any of the following procedures:
Key exclusion criteria (15 listed)
- Any condition that in the physician investigator's opinion precludes the subject's ability to comply with the study requirements
- Pregnancy
- Use of any temporary or permanent mechanical circulatory support (e.g. LVAD, extracorporeal membrane oxygenation, intra-aortic balloon pump or Impella)
- Presence of a cardiac thrombus
- Atrial fibrillation or atrial flutter without therapeutic anticoagulation or left atrial appendage occlusion device with a leak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment with Defibrio AEDtreatment with Defibrio AED to terminate VT/VF episode | Device | intervention single arm |
Primary outcome
percent detection
Time frame: end of study (within one year of first subject enrollment)
Percent detection of true shockable events
percent termination
Time frame: end of study (within one year of first subject enrollment)
Percent successful termination of VT/VF
1 secondary outcome
adverse events if any
Time frame: end of study (within one year of first subject enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. IPD will be retained as confidential during the study
Related trials for VF
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DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
Neonatal Respiratory Distress
Active, not recruiting
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
Implantable Cardioverter Defibrillator(ICD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing treatment with Defibrio AED in people with VF and VT, run by Defibrio, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barry Sands, PhD (978-358-7307, clinicalteam@rqmis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent detection (time frame: end of study (within one year of first subject enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.