Conduction DefectSTEPNCT04096365

Subcostal Temporary Extracardiac Pacing Study

A study testing Subcostal Temporary Extracardiac Pacing Lead in people with Conduction Defect, run by AtaCor Medical, Inc. at 1 site in Paraguay.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Conduction Defect
What is being tested?: Subcostal Temporary Extracardiac Pacing Lead
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteParaguay
Study dates: 25 Aug 2019to 7 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.
Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.
Physically and mentally capable of providing informed consent.
At least 18 years of age or of legal age to provide consent as required by local and national requirements.

Who cannot join

Contraindicated or clinically unsuitable for transvenous lead placement;
Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
History of a prior sternotomy (median or partial);
History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;
History of pericardial disease, pericarditis or mediastinitis;

Show all 14Show fewer

History of chronic obstructive pulmonary disease (COPD);
NYHA functional classification IV at the time of enrollment;
History of congenital heart disease;
Patients with circumstances that prevent data collection or follow-up, including conditions that prevent ambulation and testing in multiple postures;
BMI ≥ 35 kg/m2;
History of allergies to any study device components;
Pregnant or lactating (current or anticipated during study follow up); and
Participation in any concurrent study without prior, written approval from the Sponsor.

Trial locations and contacts

1 site in 1 country.

Paraguay1 site

Sanatorio Italiano
Asunción

Other trials in Paraguay

About this study

Official title: Subcostal Temporary Extracardiac Pacing Study: Clinical Study of the AtaCor Extracardiac Pacing System

Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events. Performance will be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Read the detailed description

Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. During the placement procedure, diagnostic echocardiograms will be performed to detect any new pericardial effusions. Once inserted, the StealthTrac Lead will be used to deliver high rate pacing (160 to 220 BPM) in clinically appropriate Subjects, to demonstrate suitability for use in transcatheter procedures that require brief periods of temporary pacing. Lead positions will be documented using fluoroscopic images before the Subject leaves the procedure room. On the following two days after the procedure, electrical performance will be evaluated in multiple postures and appropriate pacing and sensing will be confirmed during activity using ECG Holter monitor recordings. Subjects will also be asked patient-centric questions about their experience with the StealthTrac Lead throughout the study period. Evaluations will continue for a minimum of two (2) and a maximum of seven (7) days after the index procedure. Prior to StealthTrac Lead removal, an X-Ray will be taken to document the final lead position and diagnostic echocardiography will be performed to (1) detect any latent pericardial effusions and (2) assess differences in cardiac function with intrinsic conduction and while pacing. A final follow-up will be performed 25-30 days after removal to identify any latent adverse events before the Subject exits the study.

Conditions: Conduction Defect
Being tested: Subcostal Temporary Extracardiac Pacing 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.

Subcostal Temporary Extracardiac Pacing LeadDevice
The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.

Study groups in NCT04096365
Study group	Role	What they receive
Subcostal temporary extracardiac pacing lead	Experimental	All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing. Receives: Device: Subcostal Temporary Extracardiac Pacing Lead

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Safety will be evaluated through analysis of all Adverse Device Effects
Measured: 30 days
Performance Outcome: Mean Pacing Capture Threshold (V)
Minimum current required to pacing the heart (in multiple postures)
Measured: Up to 2 days post insertion
Performance Outcome: Mean Pacing Impedance (Ohms)
Impedance measured while pacing the heart (in multiple postures)
Measured: Up to 2 days post insertion
Performance Outcome: Mean R-Wave Amplitude (mV)
R-Wave amplitudes measured while sensing the heart (in multiple postures)
Measured: Up to 2 days post insertion
Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
ECG Holter Recordings obtained during periods of rest and in-hospital activity. The % of R-R intervals with appropriate pacing is calculated as the number of paced intervals that demonstrate pacing capture / the total number of pacing intervals. The % of R-R intervals with appropriate sensing is calculated as the number of intervals where pacing is appropriately delivered or inhibited (depending on the programmed settings of the pacemaker) / the total number of R-R intervals. The outcomes are presented a % of intervals and not an average of the percentages observed across patients.
Measured: Up to 2 days post insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 20197 Nov 2019

First posted19 Sep 2019
Study start25 Aug 2019
Primary completion7 Nov 2019
Study completion7 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04096365
Sponsor's protocol ID: DOC-10052
Acronym: STEP
Status last verified: Feb 2021
First submitted: 17 Sep 2019
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BIO|STREAM.CSP Study
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BIO|MASTER.CSP Study
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Active, not recruiting
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All Conduction Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subcostal Temporary Extracardiac Pacing Study: Clinical Study of the AtaCor Extracardiac Pacing System
ClinicalTrials.gov ID: NCT04096365
Acronym / sponsor ID: STEP / DOC-10052
Conditions: Conduction Defect
Keywords: Temporary, Ventricular, Pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: AtaCor Medical, Inc.Industry (pharma, biotech, devices)
Study start: 25 Aug 2019 (actual)
Primary completion: 7 Nov 2019 (actual)
Study completion: 7 Nov 2019 (actual)
First posted: 19 Sep 2019 (actual)
Results: Posted 3 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subcostal temporary extracardiac pacing lead	Experimental	Device: Subcostal Temporary Extracardiac Pacing LeadAll subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.
Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.
Physically and mentally capable of providing informed consent.
At least 18 years of age or of legal age to provide consent as required by local and national requirements.

Key exclusion criteria (14 listed)

Contraindicated or clinically unsuitable for transvenous lead placement;
Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
History of a prior sternotomy (median or partial);
History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;

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
Subcostal Temporary Extracardiac Pacing LeadThe StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.	Device	Subcostal temporary extracardiac pacing lead

Primary outcome

Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Time frame: 30 days
Safety will be evaluated through analysis of all Adverse Device Effects
Performance Outcome: Mean Pacing Capture Threshold (V)
Time frame: Up to 2 days post insertion
Minimum current required to pacing the heart (in multiple postures)
Performance Outcome: Mean Pacing Impedance (Ohms)
Time frame: Up to 2 days post insertion
Impedance measured while pacing the heart (in multiple postures)
Performance Outcome: Mean R-Wave Amplitude (mV)
Time frame: Up to 2 days post insertion
R-Wave amplitudes measured while sensing the heart (in multiple postures)
Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
Time frame: Up to 2 days post insertion
ECG Holter Recordings obtained during periods of rest and in-hospital activity. The % of R-R intervals with appropriate pacing is calculated as the number of paced intervals that demonstrate pacing capture / the total number of pacing intervals. The % of R-R intervals with appropriate sensing is calculated as the number of intervals where pacing is appropriately delivered or inhibited (depending on the programmed settings of the pacemaker) / the total number of R-R intervals. The outcomes are presented a % of intervals and not an average of the percentages observed across patients.

Results and safety

Results posted to the registry on 3 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subcostal Temporary Extracardiac Pacing Lead	12	11

Primary outcome: Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Subcostal Temporary Extracardiac Pacing Lead n = 11
Value	2

Primary outcome: Performance Outcome: Mean Pacing Capture Threshold (V)

Time frame: Up to 2 days post insertion. Mean (Standard Deviation). Unit: Volts

Measure	Subcostal Temporary Extracardiac Pacing Lead n = 11
Day 0 (Procedure)	4.1 (1.4)
Day 1	5.6 (2.7)
Day 2	7.0 (2.6)

Population analysed: One suspected lead dislodgement prevented measurements in all 11 subjects on Day 1 and Day 2.

Primary outcome: Performance Outcome: Mean Pacing Impedance (Ohms)

Time frame: Up to 2 days post insertion. Mean (Standard Deviation). Unit: Ohms

Measure	Subcostal Temporary Extracardiac Pacing Lead n = 11
Day 0	557 (176)
Day 1	320 (115)
Day 2	266 (60)

Population analysed: All eleven (11) Subjects contribute data on Day 0. On Day 1 and Day 2, nine (9) Subjects contribute data and two (2) Subjects do not due to a suspected lead dislodgement and one measurement out of range.

Primary outcome: Performance Outcome: Mean R-Wave Amplitude (mV)

Time frame: Up to 2 days post insertion. Mean (Standard Deviation). Unit: millivolts

Measure	Subcostal Temporary Extracardiac Pacing Lead n = 4
Day 0	4.9 (1.7)
Day 1	2.7 (1.3)
Day 2	2.6 (1.4)

Population analysed: Only 4 of 11 subjects had an intrinsic rhythm for measurement of R waves.

Adverse events

Time frame: 30 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subcostal Temporary Extracardiac Pacing Lead	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Conduction Defect

RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingObservational study
BIO|STREAM.CSP Study
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BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)

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 Burke, D.O. principal investigator

AtaCor Medical

Adrian Ebner, M.D. principal investigator

Sanatorio Italiano

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Subcostal Temporary Extracardiac Pacing Lead in people with Conduction Defect, 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 4 inclusion and 14 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 3 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Outcome: Number of Subjects Experiencing an Adverse Device Effect (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04096365.

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 3 Feb 2021.