Indications for VVI(R) Pacemaker Clinical Trial
Official title:
Nanostim Study for a Leadless Cardiac Pacemaker System
| NCT number | NCT02051972 |
| Other study ID # | LCP005 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2013 |
| Est. completion date | December 22, 2021 |
| Verified date | April 2022 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
| Status | Completed |
| Enrollment | 491 |
| Est. completion date | December 22, 2021 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and - Subject =18 years of age; and - Subject has life expectancy of at least one year and is a suitable candidate based on overall health and well-being; and - Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; and - Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and - Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and - Subject is not pregnant and does not plan on getting pregnant during the course of the study. Exclusion Criteria: - Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or - Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or - Mechanical tricuspid valve prosthesis; or - Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or - Pre-existing ventricular pacing or defibrillation leads; or - Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or - Presence of implanted vena cava filter; or - Evidence of thrombosis in one of the veins used for access during the procedure; or - Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or - Presence of implanted leadless cardiac pacemaker |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Na Homolce Hospital | Prague | |
| France | CHRU Albert Michallon | Grenoble | |
| France | Hopital La Timone | Marseille | |
| France | Nouvelles cliniques Nantaises | Nantes | |
| France | CHRU Hopital de Pontchaillou | Rennes | |
| France | CHU Strasbourg - Hôpital de Hautepierre | Strasbourg | |
| Germany | Kerckhoff-Klinik gGmbH | Bad nauheim | |
| Germany | Universitätsmedizin Berlin - Campus Benjamin Franklin | Berlin | |
| Germany | Klinikum Bielefeld gGmbH Klinikum-Mitte | Bielefeld | |
| Germany | Herzzentrum Dresden GmbH Universitätsklinik | Dresden | |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | Kath. Krankenhaus Marienhospital | Herne | |
| Germany | Herzzentrum Leipzig GmbH | Leipzig | |
| Germany | Deutsches Herzzentrum München des Freistaates Bayern | München | |
| Germany | Kliniken Villingen-Schwenningen | Villingen-Schwenningen | |
| Italy | Az. Osp. Spedali Civili di Brescia | Brescia | |
| Italy | Ospedale San Raffaele | Milan | |
| Italy | Centro Cardiologico Monzino | Milano | |
| Italy | Ospedale Niguarda Ca'Granda | Milano | |
| Italy | Policlinico San Donato | San Donato Milanese | |
| Italy | Azienda Ospedaliera Bolognini | Seriate | |
| Netherlands | AMC | Amsterdam | |
| Netherlands | Isala Klinieken | Zwolle | |
| Spain | Hospital Infanta Cristina | Badajoz | |
| Spain | Hospital Universitario de la Paz | Madrid | |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| Spain | Hospital Universitario Donostia | San Sebastián | |
| Spain | Hospital do Meixoeiro | Vigo | |
| United Kingdom | Royal Brompton Hospital | London | |
| United Kingdom | St. Bartholomew's Hospital | London | |
| United Kingdom | Manchester Heart Center, Manchester Royal Infirmary | Manchester | |
| United Kingdom | John Radcliffe Hospital | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Complication free-rate | A complication is defined as a serious adverse device effect | 5 years | |
| Other | Complication free-rate | A complication is defined as a serious adverse device effect | 90 days | |
| Primary | Complication free-rate | A complication is defined as a serious adverse device effect | 6 months |