Clinical trial NCT05895097: Conventional Versus Left Bundle Branch Pacing in TAVI
Official title: Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Failure
Pacemaker-Induced Cardiomyopathy
Transcatheter Aortic Valve Implantation
Keywords: Transcatheter Aortic Valve Implantation
Left bundle branch pacing
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
* Left ventricular ejection fraction \< 50 %.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 12 months
Secondary outcomes:
measure: Left ventricular systolic diameter
timeFrame: 12 months
measure: Left ventricular diastolic diameter
timeFrame: 12 months
measure: Global work index
timeFrame: 12 months
measure: Global constructive work
timeFrame: 12 months
measure: Global wasted work
timeFrame: 12 months
measure: Global work efficiency
timeFrame: 12 months
measure: Signs of mechanical dyssynchrony
timeFrame: 12 months
measure: Systolic pulmonary artery pressure (echocardiographic parameter)
timeFrame: 12 months
measure: NT-proBNP concentration
timeFrame: 6 and 12 months
measure: NYHA status
timeFrame: 6 and 12 months
measure: 6-minute walking test
timeFrame: 6 and 12 months
measure: Hand grip test
timeFrame: 6 and 12 months
measure: The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 6 and 12 months
measure: QRS duration
timeFrame: baseline, 6, and 12 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: