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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator.
Purpose :
To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months.
Objectives:
The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months.
The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes.
This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study.
All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Right ventricular lead located in Mid Septum |
|
| 2 | Active Comparator | Right ventricular lead located in Apex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D Therapy | Device | Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| left ventricular end systolic volume (LVESV) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| left ventricular end systolic volume | 12 months |
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Inclusion Criteria:
Accepted CRT indication according to ESC with
Or the previous criteria 1 and 2 and a transient episode in NYHA class III or IV with prior HF hospitalization or intravenous decongestive therapy (IV diuretics, IV neseritide or IV inotropes) in an "out-patient" setting within the year previous enrolment and stabilization to NYHA class II for the last month with a QRS ≥150 ms documented on ECG recording during hospitalisation
ICD indication (class I or II A)
Optimal and stable medication for at least one month (except for diuretics stable for minimum 1 week) based on ESC guidelines before the enrolment
Chronic heart failure (> 3 months) stable for the last month previous enrolment
Stable sinus rhythm at the enrolment
Willing and capable of providing informed consent
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Leclercq, MD | Hopital Pontchaillou - Rennes- France | Principal Investigator |
| Ignacio Fernández Lozano, MD | Hospital Puerta de Hierro - Madrid - Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Angers | Angers | 49033 | France | |||
| Hôpital Louis Pradel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26374852 | Derived | Leclercq C, Sadoul N, Mont L, Defaye P, Osca J, Mouton E, Isnard R, Habib G, Zamorano J, Derumeaux G, Fernandez-Lozano I; SEPTAL CRT Study Investigators. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study. Eur Heart J. 2016 Feb 1;37(5):473-83. doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 1, 2021 | |
| Reset | Jul 21, 2021 | |
| Release | Aug 22, 2023 |
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|
| Bron |
| 69677 |
| France |
| Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon | Grenoble | 38043 | France |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59037 | France |
| Hôpital Saint Joseph | Marseille | 13008 | France |
| Centre Hospitalier Universitaire de Marseille- Hôpital La Timone | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Centre Hospitalier Régional d'Orléans- Hôpital La Source | Orléans | 45067 | France |
| Hôpital La Pitié Salpétrière | Paris | 75013 | France |
| Centre Hospitalier Universitaire Haut Levêque | Pessac | 33604 | France |
| Centre Hospitaler Universitaire Pontchaillou | Rennes | 35033 | France |
| Centre Hospitalier Universitaire-Charles Nicolle | Rouen | 76031 | France |
| Centre Cardiologique du Nord | Saint-Denis | 93200 | France |
| Centre Hospitalier Universitaire - Hôpital Rangueil | Toulouse | 31059 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Centre Hospitalier Universitaire de Nancy- Hôpital Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Hospital general de Alicante | Alicante | 03010 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Hospital Virgen de la salud de Toledo | Toledo | 45004 | Spain |
| Hospital La Fe | Valencia | 46009 | Spain |
| Hospital Universitario Río Hortega | Valladolid | 04710 | Spain |
| Reset | Mar 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2021 | Jul 21, 2021 | |||
| Aug 22, 2023 | Mar 14, 2024 |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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