Conventional Versus Left Bundle Branch Pacing in TAVI
- Conditions
- Heart FailureAortic Valve StenosisPacemaker-Induced CardiomyopathyTranscatheter Aortic Valve Implantation
- Interventions
- Device: Left bundle branch pacemakerDevice: Conventional pacing
- Registration Number
- NCT05895097
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief Summary
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
- Detailed Description
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
- Left ventricular ejection fraction < 50 %.
- Unsuccessful TAVI procedure with life expectancy < 1 year
- Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
- Severe kidney failure (glomerular filtration rate < 30 ml/min)
- Previous permanent pacemaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LBB pacing Left bundle branch pacemaker - Conventional pacing Conventional pacing -
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction 12 months
- Secondary Outcome Measures
Name Time Method Left ventricular systolic diameter 12 months NT-proBNP concentration 6 and 12 months NYHA status 6 and 12 months 6-minute walking test 6 and 12 months Hand grip test 6 and 12 months QRS duration baseline, 6, and 12 months Left ventricular diastolic diameter 12 months Global constructive work 12 months Positive work performed in systole + negative work performed in isovolumetric relaxation
Global work index 12 months Amount of myocardial work performed by the left ventricle during systole.
Global wasted work 12 months Negative work performed in systole + positive work performed in isovolumetric relaxation
Global work efficiency 12 months Percentage of constructive work over total work = Constructive work/(constructive work + wasted work)
Signs of mechanical dyssynchrony 12 months Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash.
Systolic pulmonary artery pressure (echocardiographic parameter) 12 months The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 6 and 12 months KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Trial Locations
- Locations (1)
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia