TachycardiaNPC01PRGNCT02941250
Acute Defibrillation Performance of a Novel Can-less Shock Pathway
A study testing ISSD emulator in people with Tachycardia, run by NewPace Ltd at 1 site in Czechia.
Trial summary
Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia
- What is being tested?
- ISSD emulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2016to Apr 2017
- 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
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.
Read the 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.
- Conditions
- Tachycardia
- Being tested
- ISSD emulator
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISSD emulatorDevice
induced tachy-arrhythmia to be terminated by ISSD emulator
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | patients receiving ISSD emulator Receives: Device: ISSD emulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillation Threshold (DFT)
lowest shock energy required to terminate tachy-arrhythmia
Measured: immediately following induce tachy-arrhythmia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewPace Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, Prof., Principal investigator, Chief of Cardiology, Na Homolce Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941250
- Sponsor's protocol ID
- NPC01PRG
- Acronym
- NPC01PRG
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Defibrillation Performance of a Novel Can-less Shock Pathway
- ClinicalTrials.gov ID
- NCT02941250
- Acronym / sponsor ID
- NPC01PRG / NPC01PRG
- Conditions
- Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NewPace LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: ISSD emulatorpatients receiving ISSD emulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| ISSD emulatorinduced tachy-arrhythmia to be terminated by ISSD emulator | Device | treatment |
Primary outcome
Defibrillation Threshold (DFT)
Time frame: immediately following induce tachy-arrhythmia
lowest shock energy required to terminate tachy-arrhythmia
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 15 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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.
Petr Neuzil, Prof. principal investigator
Chief of Cardiology, Na Homolce Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISSD emulator in people with Tachycardia, run by NewPace Ltd at 1 site in Czechia.
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 5 inclusion and 13 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 15 Sep 2017. 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 Czechia. 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?
Defibrillation Threshold (DFT) (time frame: immediately following induce tachy-arrhythmia). 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 15 Sep 2017.