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Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.
One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.
The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRIV | Experimental | Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead) |
|
| BIV | Active Comparator | Conventional cardiac resynchronization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT with triple site ventricular stimulation | Device | CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of triple site CRT compared to conventional CRT | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of triple site CRT | 6 months | |
| Left ventricle remodeling | At 3 and 6 months | |
| LV ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Anselme, Pr | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Bordeaux | Bordeaux | 33000 | France | |||
| University hospital of Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26325531 | Derived | Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26. |
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| Conventional cardiac resynchronization | Device | Conventional cardiac resynchronization |
|
| At 3 and 6 months |
| Cardiac dyssynchrony | At 3 and 6 months |
| Functional status (clinical composite score and NYHA class) | At 3 and 6 months |
| Exercise capacity (6 minutes hall walk test distance) | At 3 and 6 months |
| Quality of life | At 3 and 6 months |
| B-Type Natriuretic Peptide (BNP) level | 6 months |
| Lille |
| 59000 |
| France |
| University hospital La Timone | Marseille | 13000 | France |
| University hospital of Montpellier | Montpellier | 34000 | France |
| University hospital of Nancy | Nancy | 54000 | France |
| Nouvelles Cliniques Nantaises | Nantes | 44000 | France |
| University hospital of Nantes | Nantes | 44000 | France |
| Clinique Bizet | Paris | 75016 | France |
| University Hospital of Rennes | Rennes | 35000 | France |
| University hospital of Rouen | Rouen | 76031 | France |
| Centre Cardiologique du Nord | Saint-Denis | 93200 | France |
| Hôpital Saint Louis | La Rochelle | Île-de-France Region | 17000 | France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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