Ventricular ArrhythmiaSECURE EVNCT05352776
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
A study testing AtaCor EV-ICD Lead in people with Ventricular Arrhythmia and Ventricular Tachycardia, run by AtaCor Medical, Inc. at 1 site in Paraguay.
Trial summary
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- AtaCor EV-ICD Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteParaguay
- Study dates
- 18 May 2022to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years old
- Indicated for de novo or replacement ICD procedure
Who cannot join
- NYHA IV functional class
- BMI ≥ 35 kg/m2
- Inotropic therapy in past 180 days
- Subjects who require continual ventricular pacing
- Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
- Planned MRI within the study period
Show all 22Show fewer
- Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
- Logistical or safety related circumstances that may prevent data collection or follow-up
- Participation in any concurrent clinical study without prior written approval from the Sponsor
- Inability to give an informed consent to participate in the Study
- Known prior history for any of the following:
- Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead
- Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
- Median or partial sternotomy
- Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
- Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
- Pericardial disease, pericarditis and mediastinitis
- Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- FEV1 < 1.0 Liter
- Surgically corrected congenital heart disease (not including catheter-based procedures)
- Allergies to the device materials as listed in the Instructions for Use (IFU)
Trial locations and contacts
1 site in 1 country.
About this study
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.
Read the detailed description
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant.
Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days.
Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period.
After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first enrollment.
- Being tested
- AtaCor EV-ICD Lead
- Keywords
- Ventricular Defibrillation, Extravascular
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaCor EV-ICD LeadDevice
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
| Study group | Role | What they receive |
|---|---|---|
| AtaCor EV-ICD Lead System | Experimental | Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001 Receives: Device: AtaCor EV-ICD Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ADEs
Incidence of Adverse Device Effects (ADEs)
Measured: Up to 120 days post-implant
Induced VF Conversion Success
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Measured: Up to 90 days post-implant
Secondary outcomes (9)
Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
Measured: Procedure
Induced VF Conversion Success - Implant
Induced VF conversion success rate at implant with left pectoral PG location
Measured: Procedure
Induced VF Conversion Success - 30 Days
Induced VF conversion success with ≥10 J safety margin at 30 days
Measured: Up to 30 days post-implant
Sensing and Detection of Ventricular Arrhythmias
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
Measured: Up to 90 days post-implant
Detection Time for VT/VF
Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System
Measured: Up to 90 days post-implant
Detection Time and Time-to-Therapy
EV-ICD VF detection time and time-to-therapy
Measured: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Capture Threshold
Pacing Capture Threshold (V)
Measured: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Impedance
Pacing Impedance (ohms)
Measured: Up to 90 days post-implant
Brady Pacing Electrical Performance: R-wave Amplitude
R-wave Amplitude (mV)
Measured: Up to 90 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start18 May 2022
- Primary completion21 Sep 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiaStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtaCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin C Burke, DO, Principal investigator, AtaCor Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352776
- Sponsor's protocol ID
- DOC-10181
- Acronym
- SECURE EV
- Status last verified
- Aug 2023
- First submitted
- 22 Apr 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
- ClinicalTrials.gov ID
- NCT05352776
- Acronym / sponsor ID
- SECURE EV / DOC-10181
- Keywords
- Ventricular Defibrillation, Extravascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 29 Apr 2022 (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 SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.
Detailed description
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant.
Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days.
Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period.
After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first enrollment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtaCor EV-ICD Lead System | Experimental | Device: AtaCor EV-ICD LeadSubjects implanted with the AtaCor EV-ICD Lead Model AC-7001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years old
- Indicated for de novo or replacement ICD procedure
Key exclusion criteria (22 listed)
- NYHA IV functional class
- BMI ≥ 35 kg/m2
- Inotropic therapy in past 180 days
- Subjects who require continual ventricular pacing
- Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
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 |
|---|---|---|
| AtaCor EV-ICD LeadSubjects will receive the AtaCor EV-ICD Lead being evaluated in the study. | Device | AtaCor EV-ICD Lead System |
Primary outcome
Incidence of ADEs
Time frame: Up to 120 days post-implant
Incidence of Adverse Device Effects (ADEs)
Induced VF Conversion Success
Time frame: Up to 90 days post-implant
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
9 secondary outcomes
Lowest Defibrillation Conversion Energy
Time frame: Procedure
Induced VF Conversion Success - Implant
Time frame: Procedure
Induced VF Conversion Success - 30 Days
Time frame: Up to 30 days post-implant
Sensing and Detection of Ventricular Arrhythmias
Time frame: Up to 90 days post-implant
Detection Time for VT/VF
Time frame: Up to 90 days post-implant
Detection Time and Time-to-Therapy
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Capture Threshold
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Impedance
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: R-wave Amplitude
Time frame: Up to 90 days post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Martin C Burke, DO principal investigator
AtaCor Medical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtaCor EV-ICD Lead in people with Ventricular Arrhythmia and Ventricular Tachycardia, run by AtaCor Medical, Inc. at 1 site in Paraguay.
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 2 inclusion and 22 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: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ADEs (time frame: Up to 120 days post-implant). 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 29 Aug 2023.