Ventricular ArrhythmiaPASS PULLNCT05099289
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) 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 PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. 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
- 17 Nov 2021to 31 Mar 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 with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing
- Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
- Subjects on anticoagulation/antiplatelet therapy that cannot be temporarily discontinued for the procedure
Show all 21Show fewer
- 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 as assessed from available CT or Echocardiography.
- 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 PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Read the detailed description
The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for enrollment.
- Being tested
- AtaCor EV-ICD Lead
- Keywords
- Ventricular Defibrillation
- 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 inserted with the AtaCor EV-ICD Lead Model AC-7000 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 SADEs
Incidence of Serious Adverse Device Effects (SADEs)
Measured: Up to 10 days post-procedure
Rate of Insertion Success
Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs
Measured: Procedure
Secondary outcomes (2)
Functionality - Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J)
Measured: Procedure
Observational: Incidence of ADEs
Incidence of Adverse Device Effects (ADEs), Overall and Individual
Measured: Up to 10 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start17 Nov 2021
- Primary completion17 Feb 2022
- Study completion31 Mar 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
- Basic science
- 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
- NCT05099289
- Sponsor's protocol ID
- DOC-10154
- Acronym
- PASS PULL
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2021
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
- ClinicalTrials.gov ID
- NCT05099289
- Acronym / sponsor ID
- PASS PULL / DOC-10154
- Keywords
- Ventricular Defibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 29 Oct 2021 (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 PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Detailed description
The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.
Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for enrollment.
Study design
- Primary purpose
- Basic science
- 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 inserted with the AtaCor EV-ICD Lead Model AC-7000 |
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 (21 listed)
- NYHA IV functional class
- BMI ≥ 35 kg/m2
- Inotropic therapy in past 180 days
- Subjects with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing
- Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
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 SADEs
Time frame: Up to 10 days post-procedure
Incidence of Serious Adverse Device Effects (SADEs)
Rate of Insertion Success
Time frame: Procedure
Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs
2 secondary outcomes
Functionality - Lowest Defibrillation Conversion Energy
Time frame: Procedure
Observational: Incidence of ADEs
Time frame: Up to 10 days post-procedure
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 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrhythmia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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 21 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 8 Jul 2022. 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 SADEs (time frame: Up to 10 days post-procedure). 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 8 Jul 2022.