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

Primary Purpose

Tachycardia

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

ISSD emulator

About this trial

This is an interventional treatment trial for Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nemocnice Na Homolce

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

patients receiving ISSD emulator

Outcomes

Primary Outcome Measures

Defibrillation Threshold (DFT)

lowest shock energy required to terminate tachy-arrhythmia

Secondary Outcome Measures

Full Information

NCT ID

NCT02941250

First Posted

October 8, 2016

Last Updated

September 14, 2017

Sponsor

NewPace Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02941250

Brief Title

Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Acronym

NPC01PRG

Official Title

Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NewPace Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tachycardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Arm Description

patients receiving ISSD emulator

Intervention Type

Device

Intervention Name(s)

ISSD emulator

Intervention Description

induced tachy-arrhythmia to be terminated by ISSD emulator

Primary Outcome Measure Information:

Title

Defibrillation Threshold (DFT)

Description

lowest shock energy required to terminate tachy-arrhythmia

Time Frame

immediately following induce tachy-arrhythmia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petr Neuzil, Prof.

Organizational Affiliation

Chief of Cardiology, Na Homolce Hospital, Prague

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nemocnice Na Homolce

City

Prague

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Acute Defibrillation Performance of a Novel Can-less Shock Pathway

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