Triple-site Biventricular Stimulation in the Optimization of CRT (TRIUMPH-CRT)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring non-Left Bundle Branch Block morphology, Triple-site biventricular pacing, cardiac resynchronization therapy
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
- Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Intrinsic QRS duration ≥ 140 msec
- Non-typical left bundle branch block (LBBB) morphology on 12-lead surface ECG
- Signed and dated informed consent
Exclusion Criteria:
- Typical LBBB according to Strauss criteria
- Unstable heart failure
- Permanent or long-lasting persistent Atrial Fibrillation
- Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
- Conventional pacemaker indication
- Previous implant with a pacemaker or an Implantable Cardioverter-Defibrillator (ICD)
- Renal Failure (Glomerular filtration rate (GFR) < 30 ml/min/1.73m2)
- Pregnant women
- Already included in another clinical study that could confound the results of this study
- Life expectancy < 12 months
- Mechanical heart valve or indication for valve repair or replacement
- Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months)
- Heart transplant
Sites / Locations
- CHRU Hopital Sud
- Clinique Rhone Durance
- Hopital Jean Minjoz Besançon
- CHRU Brest
- Groupe hospitalier Paris Saint-Joseph
- CHU Poitiers
- CHU Hôpital Charles Nicolle
- CHU Toulouse, Hopital Rangueil
- Universitaetsklinikum Schleswig Holstein
- Humanitas Cliniche Gavazzeni spa
- Isala Zwolle
- CHCL - Hospital Santa Marta
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario La Fe
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Triple-site biventricular pacing
Standard biventricular pacing
Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance. Devices used will be the Sorin, locally approved and commercially available Paradym SonR Tri-V CRT-D.
Standard biventricular pacing (1RV/1LV) through classical implantation procedure without peri-operative optimization. Devices used will be locally approved and commercially available Sorin implantable cardioverter defibrillators.