Arrythmia, Implatable Cardioverter Defibrillation, Lead Clinical Trial
— NAVIGATOROfficial title:
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
| Verified date | January 2019 |
| Source | MicroPort CRM |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector
| Status | Active, not recruiting |
| Enrollment | 317 |
| Est. completion date | March 2022 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - Any patient presenting a CRT-D indication as detailed in the ESC guidelines - Primary implant of a PLATINIUM 4LV CRTD or upgrade from an existing ICD connected to a RV lead with a DF4 connector (DF4LLHH) to a PLATINIUM 4LV CRT-D - Signed and dated informed consent Exclusion Criteria: - Patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (DSP) eluted from the NAVIGO 4LV lead maybe contraindicated - Venous anomalies precluding transvenous implant (contraindication of a Pacemaker or ICD implant) - Active myocarditis, pocket and/or lead infection - Stroke/myocardiaI infarction one month prior to implant - Already included in another clinical study that could confound the results of this study. - Inability to meet Follow-up visits at the implanting centre as defined in the investigational plan. - Patient less than 18 years old or under guardianship - Known pregnancy, women in lactation period or in childbearing age without an adequate contraceptive method (failure rate < 1%) - Drug addiction or abuse |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Brest | Brest | |
| France | CHRU Hopital Trousseau | Chambray-lès-Tours | |
| France | CH Robert Boulin | Libourne | |
| France | CHU Hôpital Nord - Marseille | Marseille | |
| France | Institut Hospitalier Jacques Cartier | Massy | |
| France | CH Annecy Genevois | Metz-Tessy | |
| France | Groupe Hospitalier Paris St Joseph | Paris | |
| France | Institut Mutualiste Montsouris | Paris | |
| France | CHU Bordeaux | Pessac | |
| France | CHU Hopital Charles Nicolle | Rouen | |
| France | CHU Rangueil | Toulouse | |
| France | Centre Hospitalier de Valence | Valence | |
| France | CHRU Brabois | Vandoeuvre les Nancy | |
| Germany | Herz- und Gefässzentrum Bad Bevensen | Bad Bevensen | |
| Germany | Herz- und Diabeteszentrum | Bad Oeynhausen | |
| Germany | Deutsches Herzzentrum Berlin | Berlin | |
| Germany | Evangelisches Krankenhaus | Bielefeld | |
| Germany | Klinikum Coburg | Coburg | |
| Germany | Kardiologie Darmstadt | Darmstadt | |
| Germany | Universitäts-Herzzentrum Freiburg | Freiburg | |
| Germany | Albertinen-Krankenhau | Hamburg | |
| Germany | Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | |
| Germany | Universitatsklinikum | Wurzburg | |
| Italy | Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi | Ancona | |
| Italy | Ospedale Universitario Di Pisa | Pisa | |
| Italy | Az. Osp. Univ. S. Maria della Misericordia | Udine | |
| Netherlands | ISALA Klinieken | Zwolle | |
| Portugal | Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO) | Carnaxide | |
| Portugal | Centro Hospitalar e Universitário de Coimbra - Hospital Geral | Coimbra | |
| Portugal | Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra | Coimbra | |
| Portugal | Centro H. Lisboa Norte - Hospital de Santa Maria | Lisboa | |
| Portugal | CHCL - Hospital Santa Marta | Lisbon | |
| Portugal | Centro Hospitalar do Porto CHP Hospital de Santo Antonio | Porto | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital Universitario Gregorio Marañón | Madrid | |
| Spain | H. Universitario Central de Asturias | Oviedo | |
| Spain | Hospital Universitario La Fe | Valencia | |
| Spain | Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro | Vigo |
| Lead Sponsor | Collaborator |
|---|---|
| MicroPort CRM |
France, Germany, Italy, Netherlands, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LV lead Safety at 10 weeks | Freedom from LV lead-related complications, defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) that occurred within 30 days after successful implant of the CRT-D system | 10 weeks after implant | |
| Primary | LV lead Performance at 10 weeks | Successful performance defined as LV pacing threshold at 10 weeks < 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude | 10 weeks after implant | |
| Secondary | Electrical performance | LV pacing threshold amplitude (V) and LV pacing impedance (Ohm) | through study completion, an average of 6 month | |
| Secondary | Rate of patients free from LV lead-related complications | Freedom from LV lead-related complications defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) | through study completion, an average of 6 month | |
| Secondary | LV lead-related SAEs | Serious Adverse Event LV related | through study completion, an average of 6 month | |
| Secondary | Lead handing assessment of NAVIGO 4LV leads through a questionnaire | A questionnaire on lead handling will track opinion from the investigator, comparing his assessment with this lead to device he is accustomed to implant | Implant | |
| Secondary | NAVIGO 4LV lead implant success rate on enrolled population | To report the NAVIGO 4LV lead implant success rate | Enrollment | |
| Secondary | Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation | To report the number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation | 10 weeks | |
| Secondary | Number of patients with MP pacing activated | To report the number of patients with MP pacing activated | through study completion, an average of 6 month | |
| Secondary | Rationale to activate MP | To report the reason why physician decide to activate MP to the patient | through study completion, an average of 6 month | |
| Secondary | Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude | To report the number of patients with at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude | through study completion, an average of 6 month | |
| Secondary | Number of patients at each final programmed pacing vector and changes | To report number of patients at each final programmed pacing vector and changes | through study completion, an average of 6 month |