Acute Defibrillation Performance of a Novel Can-less Shock Pathway (NPC01PRG)

Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.

Study Overview

• Status: Completed
• Conditions: Tachycardia
• Intervention / Treatment: Device: ISSD emulator

Detailed Description

The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed.

The emulator is not a powered medical device.

This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Nemocnice na Homolce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects meeting class 1, 2a or 2b indication for ICD implantation
• Age >18
• 32 > Body Mass Index (BMI) > 25
• 190 > Height > 165 cm
• 120 > Waist size > 90 cm

Exclusion Criteria:

• Any condition that precludes the subject's ability to comply with the study requirements, including completion of the study
• Female who is pregnant or breastfeeding;
• Female who is of childbearing age who does not use reliable contraception methods (e.g. contraceptive pills, Intra-Uterine Device, estrogen-containing plasters) or had a positive pregnancy test
• An acute infection requiring antibiotics two weeks prior to surgery
• Participation in any other investigational study in the time ICD implantation is planned, unless there is written consent from the study sponsor;
• Use of the antiarrhythmic drug Amiodarone (Cordarone, Sedacoron, Adenosine or other drugs) in the last 6 months before participation in the clinical trial;
• Existence of large permanent electrodes (e.g. epicardial electrodes), more than 3 permanent endocardial electrodes or any other metal object implanted in the upper part of your body;
• Any of the following cardiac diseases: protracted New York Heart Association (NYHA) class III or IV heart failure , Left Ventricular Ejection Fraction (LVEF) < 20% or an enlarged or hypertrophied heart
• Pulmonary hypertension patient, either with a history of moderate or severe pulmonary hypertension or by estimated pulmonary pressure above 45 (by cardiac echo test).
• Chronic Obstructive Pulmonary Disease (COPD) patient that have been hospitalized in the last 12 months for COPD related reasons, require oxygen support or steroid based therapeutic support.
• Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.
• Subjects with prior abdominal surgery in the upper abdomen, previous upper abdominal trauma or anatomical deformities of the chest or upper abdomen
• Subjects with known bleeding diathesis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; patients receiving ISSD emulator	Device: ISSD emulator; induced tachy-arrhythmia to be terminated by ISSD emulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defibrillation Threshold (DFT)	lowest shock energy required to terminate tachy-arrhythmia	immediately following induce tachy-arrhythmia

Collaborators and Investigators

• Sponsor: NewPace Ltd
• Investigators: Principal Investigator: Petr Neuzil, Prof., Chief of Cardiology, Na Homolce Hospital, Prague

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 8, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: NPC01PRG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED