Acute Defibrillation Performance of a Novel Can-less Shock Pathway

NCT02941250 | Completed

• 1 other identifier: NPC01PRG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia

Outcome Measures

Primary Outcomes (1)

• Defibrillation Threshold (DFT)

  lowest shock energy required to terminate tachy-arrhythmia

  immediately following induce tachy-arrhythmia

Study Arms (1)

treatment

EXPERIMENTAL

patients receiving ISSD emulator

Device: ISSD emulator

Interventions

ISSD emulator DEVICE

induced tachy-arrhythmia to be terminated by ISSD emulator

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NewPace Ltd: lead

Study Sites (1)

Nemocnice Na Homolce

Prague, Czechia

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Petr Neuzil, Prof.

  Chief of Cardiology, Na Homolce Hospital, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 21, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2016-10

Locations

CZ (1)