Conduction DefectSTEP IIINCT04538287
AtaCor Subcostal Temporary Extravascular Pacing III Study
A study testing AtaCor StealthTrac Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 4 sites in 3 countries.
Trial summary
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conduction Defect
- What is being tested?
- AtaCor StealthTrac Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Oct 2020to 11 May 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 closed-chest cardiac invasive procedure (e.g. transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)
Who cannot join
- NYHA IV functional class
- Oxygen dependency
- BMI ≥ 35 kg/m2
- Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
- Participation in any concurrent clinical study without prior written approval from the Sponsor
- Inability to give an informed consent to participate in the Study
Show all 19Show fewer
- Known prior history for any of the following:
- 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 AtaCor EV Temporary Pacing Lead System insertion procedure
- Pericardial disease, pericarditis and mediastinitis
- Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- Severe to very severe airflow limitation, defined as FEV1/FVC <0.7 AND FEV1 < 50% predicted
- Symptomatic COPD exacerbation associated with either:
- Modified MRC Dyspnea Scale Grade ≥2, OR
- CAT Assessment
- Surgically corrected congenital heart disease (not including catheter-based procedures)
- Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
New Zealand2 sites
Christchurch Hospital
Christchurch
Wellington Regional Hospital
Wellington
About this study
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.
The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.
Read the detailed description
Prior revisions of the study intended to evaluate multiple StealthTrac Leads (Models AC-1010, AC-1020, AC-2021 and AC-1030) to support the development of a future pivotal study. In the most recent revision of the study, an additional StealthTrac Lead (Model AC-1012) will be evaluated to support use in a larger pivotal study.
This study is a feasibility study serving dual purposes: 1) to generate developmental clinical data in support of a subsequent pivotal clinical study and marketing application for temporary pacing (in patients that retain the lead for a maximum of 7 days); and 2) to obtain early data for future research related to longer-term use (in patients that retain the lead for a maximum of 14 days).
Subjects undergoing a qualifying index procedure will have a Model AC-1012 StealthTrac Lead inserted, evaluated for a Maximum Lead Insertion Time prior to removal and a final post-removal follow-up 27-33 days after lead insertion. The following elements will change after the absence of AtaCor-related cardiac tamponade and no more than one (1) serious AtaCor-related pericardial effusion has been confirmed from the initial eight (8) experiences with the Model AC-1012 StealthTrac Lead, including insertion and removal procedures performed by multiple operators:
- Maximum Lead Insertion Time will change from 7 to 14 Days
- Follow-up will change from in-hospital follow-up only to allowing hospital discharge with the StealthTrac lead inserted, but capped and inactive after Day 2 provided in-person wound checks occur at least every 3 days
- Echocardiography requirements will transition from 3 distinct days to procedure day and removal day only.
- Conditions
- Conduction Defect
- Being tested
- AtaCor StealthTrac Lead
- Keywords
- Temporary Ventricular Pacing
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaCor StealthTrac LeadDevice
Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.
| Study group | Role | What they receive |
|---|---|---|
| AtaCor StealthTrac Lead Model AC-1010 | Active comparator | Subjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study. Receives: Device: AtaCor StealthTrac Lead |
| AtaCor StealthTrac Lead Model AC-1020 | Active comparator | Subjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study. Receives: Device: AtaCor StealthTrac Lead |
| AtaCor StealthTrac Lead Model AC-1021 | Active comparator | Subjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study. Receives: Device: AtaCor StealthTrac Lead |
| AtaCor StealthTrac Lead Model AC-1012 | Active comparator | Subjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study. Receives: Device: AtaCor StealthTrac Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Freedom from Adverse Device Effects
Freedom from Adverse Device Effects (ADE)
Measured: Lead removal (up to 14 Days)
Performance - Pacing Capture Threshold
Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal
Measured: Lead removal (up to 14 Days)
Performance - Pacing Impedance
Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal
Measured: Lead removal (up to 14 Days)
Performance - Sensed R-wave Amplitude
Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal
Measured: Lead removal (up to 14 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start3 Oct 2020
- Primary completion25 Jan 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction DefectStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT04538287
- Sponsor's protocol ID
- DOC-10092
- Acronym
- STEP III
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2020
- Last updated
- 7 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtaCor Subcostal Temporary Extravascular Pacing III Study
- ClinicalTrials.gov ID
- NCT04538287
- Acronym / sponsor ID
- STEP III / DOC-10092
- Conditions
- Conduction Defect
- Keywords
- Temporary Ventricular Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 4 Sep 2020 (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.
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.
The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.
Detailed description
Prior revisions of the study intended to evaluate multiple StealthTrac Leads (Models AC-1010, AC-1020, AC-2021 and AC-1030) to support the development of a future pivotal study. In the most recent revision of the study, an additional StealthTrac Lead (Model AC-1012) will be evaluated to support use in a larger pivotal study.
This study is a feasibility study serving dual purposes: 1) to generate developmental clinical data in support of a subsequent pivotal clinical study and marketing application for temporary pacing (in patients that retain the lead for a maximum of 7 days); and 2) to obtain early data for future research related to longer-term use (in patients that retain the lead for a maximum of 14 days).
Subjects undergoing a qualifying index procedure will have a Model AC-1012 StealthTrac Lead inserted, evaluated for a Maximum Lead Insertion Time prior to removal and a final post-removal follow-up 27-33 days after lead insertion. The following elements will change after the absence of AtaCor-related cardiac tamponade and no more than one (1) serious AtaCor-related pericardial effusion has been confirmed from the initial eight (8) experiences with the Model AC-1012 StealthTrac Lead, including insertion and removal procedures performed by multiple operators:
- Maximum Lead Insertion Time will change from 7 to 14 Days
- Follow-up will change from in-hospital follow-up only to allowing hospital discharge with the StealthTrac lead inserted, but capped and inactive after Day 2 provided in-person wound checks occur at least every 3 days
- Echocardiography requirements will transition from 3 distinct days to procedure day and removal day only.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AtaCor StealthTrac Lead Model AC-1010 | Active comparator | Device: AtaCor StealthTrac LeadSubjects inserted with the AtaCor StealthTrac Lead Model AC-1010. This was the first model evaluated in the study. |
| AtaCor StealthTrac Lead Model AC-1020 | Active comparator | Device: AtaCor StealthTrac LeadSubjects inserted with the AtaCor StealthTrac Lead Model AC-1020. This was the second model evaluated in the study. |
| AtaCor StealthTrac Lead Model AC-1021 | Active comparator | Device: AtaCor StealthTrac LeadSubjects inserted with the AtaCor StealthTrac Lead Model AC-1021. This was the third model evaluated in the study. |
| AtaCor StealthTrac Lead Model AC-1012 | Active comparator | Device: AtaCor StealthTrac LeadSubjects inserted with the AtaCor StealthTrac Lead Model AC-1012. This is the fourth model currently being evaluated in the study. |
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 closed-chest cardiac invasive procedure (e.g. transcatheter valve replacement, balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions)
Key exclusion criteria (19 listed)
- NYHA IV functional class
- Oxygen dependency
- BMI ≥ 35 kg/m2
- Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
- Participation in any concurrent clinical study without prior written approval from the Sponsor
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 StealthTrac LeadSubjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study. | Device | AtaCor StealthTrac Lead Model AC-1010, AtaCor StealthTrac Lead Model AC-1012, AtaCor StealthTrac Lead Model AC-1020, AtaCor StealthTrac Lead Model AC-1021 |
Primary outcome
Safety - Freedom from Adverse Device Effects
Time frame: Lead removal (up to 14 Days)
Freedom from Adverse Device Effects (ADE)
Performance - Pacing Capture Threshold
Time frame: Lead removal (up to 14 Days)
Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal
Performance - Pacing Impedance
Time frame: Lead removal (up to 14 Days)
Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal
Performance - Sensed R-wave Amplitude
Time frame: Lead removal (up to 14 Days)
Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal
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 7 Jul 2022.
- Individual participant dataSharing planned: No
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtaCor StealthTrac Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 4 sites in 3 countries.
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 19 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 7 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 4 sites in New Zealand, Czechia, 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?
Safety - Freedom from Adverse Device Effects (time frame: Lead removal (up to 14 Days)). The study lists 4 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 7 Jul 2022.