Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
Study Details
Study Description
Brief Summary
STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate early safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. Safety will be characterized through analysis of all adverse events through 6 weeks post-implant and 30 days post-explant. VF sensing and conversion of induced VF with the EV-ICD Lead over a 6 week implant period will be evaluated. Pacing and subject sensation while pacing will also be evaluated over the study period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary safety endpoint is Incidence of Adverse Device Effects (ADEs). The primary performance endpoint is Induced VF conversion success with ≥ 10J safety margin at 6 weeks. Secondary endpoints include pacing capture threshold, pacing impedance, R-wave amplitudes and sensation level while pacing.
Up to 30 eligible Subjects undergoing a pectoral transvenous ICD procedure (de novo or replacement) will receive an EV-ICD Lead connected to a commercially available ICD in a left mid-axillary pocket.
The EV-ICD System will be tested acutely to determine the lowest defibrillation energy. Subjects will remain in the hospital overnight minimum, prior to discharge. Before discharge, the EV-ICD will be programmed to monitor only (therapy OFF) to detect and store ventricular arrhythmias over the follow-up period. Other non-therapy programming parameters will match the transvenous ICD to the extent possible.
Follow-up visits are planned at 2 weeks (Day 11 to 17) and 6 weeks (Day 35 to 45). VF conversion testing will occur again at the 6-week visit to determine if a ≥10J safety margin exists.
The EV-ICD System will be removed on completion of the 6-week visit, leaving the transvenous ICD system in place. A post-removal follow-up to assess any post-removal adverse events will occur 25-35 days post-removal, prior to study exit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AtaCor EV-ICD Lead System Subjects implanted with the AtaCor EV-ICD Lead |
Device: AtaCor EV-ICD Lead
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
|
Outcome Measures
Primary Outcome Measures
- Incidence of ADEs [6 weeks post-implant]
Incidence of Adverse Device Effects (ADEs) at 6 weeks
- Induced VF Conversion Success [6 weeks post-implant]
Induced VF conversion success rate at 6 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years old
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Indicated for de novo or replacement ICD procedure
Exclusion Criteria:
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BMI ≥ 35 kg/m2
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Subjects who require continual ventricular pacing
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Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period
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Planned MRI within the study period
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Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
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Circumstances that may prevent data collection or follow-up
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Participation in any concurrent clinical study without prior written approval from the Sponsor
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Inability or unwillingness to provide informed consent to participate in the Study
Known prior history for any of the following:
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NYHA IV functional class in past 90 days
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Inotropic therapy in past 180 days
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Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
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Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
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Median or partial sternotomy
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Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
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Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
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Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV-ICD Lead System implant procedure
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Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
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Pericardial disease, pericarditis and mediastinitis
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Medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
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FEV1 < 1.0 Liter
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Surgically corrected congenital heart disease (not including catheter-based procedures)
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Allergies to the device materials as listed in the Instructions for Use (IFU)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanatorio Italiano | Asunción | Paraguay |
Sponsors and Collaborators
- AtaCor Medical, Inc.
Investigators
- Principal Investigator: Martin C Burke, DO, AtaCor Medical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DOC-10246