Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.
The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.
All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:
PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.
The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.
Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Slow VT zone programmed as a "Monitoring" zone (Monitoring arm) |
|
| 2 | Experimental | Slow VT zone programmed with ATP therapies (therapy arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovatio CRT 6750 | Device | Slow VT zone programmed as a "Monitoring" zone (Monitoring arm) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts; | 24 months | |
| ATP therapy efficacy on slow VTs conversion. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV) | 24 months | |
| Tvar risk stratification | 24 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Bauer | Universitätsklinikum Heidelberg, 69120 Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis | Antwepen | 2060 | Belgium | |||
| Grey-Nuns Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ovatio CRT 6750 |
| Device |
Slow VT zone programmed with ATP therapies (therapy arm). |
|
| "unscheduled visits" or "hospital re-admissions" due to slow VTs; |
| 24 months |
| Incidence of adverse events (AEs) in the studied population | 24 months |
| Edmonton |
| T5A 0A1 |
| Canada |
| Royal Alexandra Hospital | Edmonton | T5A 0A1 | Canada |
| Laval UH, Ste Foy | Québec | G1R 4E4 | Canada |
| CH Albi | Albi | France |
| CH Angers | Angers | 49000 | France |
| Hôpital privé d'Antony | Antony | France |
| Hôpital Haut Lévèque | Bordeaux | France |
| Hôpital de la Cavalle Blanche | Brest | France |
| Clinique de Parly II | Le Chesnay | France |
| CH St Philibert | Lomme | France |
| CHU Hopital La Timone | Marseille | 13000 | France |
| CHU Hôpital Nord - Marseille | Marseille | 13000 | France |
| CHU Hôpital Nord | Marseille | 13000 | France |
| Clinique Beauregard | Marseille | 13000 | France |
| Clinique Clairval | Marseille | 13000 | France |
| Hôpital Arnaud de Villeneu | Montpellier | France |
| Clinique Amboise Paré | Neuilly | France |
| CHU Hopital Pasteur | Nice | 6000 | France |
| CHU Groupe Carémeau | Nîmes | 30000 | France |
| C.H.R Hopital De La Source | Orléans | 45000 | France |
| Clinique Bizet | Paris | France |
| CH Pau | Pau | 64000 | France |
| Hôpital de la Miletrie | Poitiers | France |
| CHU Charles Nicolle | Rouen | France |
| Centre Cardiologique Du Nord | Saint-Denis | 93200 | France |
| CHU Hôpital Nord | Saint-Etienne | 42000 | France |
| Hopital Font Pré | Toulon | 83000 | France |
| Hôpital Purpan | Toulouse | France |
| Herzkreislaufklinik | Bad Bevensen | Germany |
| Kerckhoff-Klinik GmbH | Bad Nauheim | Germany |
| Praxis Westend | Berlin | 10871 | Germany |
| Universitatsklinik Med. Klinik Heidelberg | Heidelberg | 69118 | Germany |
| Universität des Saarlandes | Homburg | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Germany |
| Uniklinik Munster | Münster | Germany |
| Krankenhaus Reinbek | Reinbek | Germany |
| Ospedale Civile Di Asti | Asti | 14100 | Italy |
| Casa di cura villa pini d'abruzo | Chieti | Italy |
| Hospital Clinico | Valencia | 46006 | Italy |
| Hospital Fernando Fonseca | Amadora | Portugal |
| CHUVI | Vigo | 36200 | Spain |
| Danderyds Sjukhus Ab | Danderyd | 18211 | Sweden |
| Orebro Universitetssjukhus | Örebro | 70015 | Sweden |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Glenfield Hospital | Leicester | LE19 | United Kingdom |
| St Barts Hospital | London | United Kingdom |
| Northern General Hospital | Sheffield | United Kingdom |
| Southampton General Hospital | Southampton | United Kingdom |