Conventional Versus Left Bundle Branch Pacing in TAVI

Heart Failure Clinical Trial

Official title:

Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05895097
• Other study ID #: PACE TAVI
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 15, 2026

Study information

• Verified date: June 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiomyopathies
• Heart Failure
• Transcatheter Aortic Valve Implantation

Intervention

Device:
• Left bundle branch pacemaker
Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.
• Conventional pacing
Right ventricular pacing in patients with LVEF = 40% and cardiac resynchronization therapy in patients with LVEF < 40 %

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		12 months
Secondary	Left ventricular systolic diameter		12 months
Secondary	Left ventricular diastolic diameter		12 months
Secondary	Global work index	Amount of myocardial work performed by the left ventricle during systole.	12 months
Secondary	Global constructive work	Positive work performed in systole + negative work performed in isovolumetric relaxation	12 months
Secondary	Global wasted work	Negative work performed in systole + positive work performed in isovolumetric relaxation	12 months
Secondary	Global work efficiency	Percentage of constructive work over total work = Constructive work/(constructive work + wasted work)	12 months
Secondary	Signs of mechanical dyssynchrony	Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash.	12 months
Secondary	Systolic pulmonary artery pressure (echocardiographic parameter)		12 months
Secondary	NT-proBNP concentration		6 and 12 months
Secondary	NYHA status		6 and 12 months
Secondary	6-minute walking test		6 and 12 months
Secondary	Hand grip test		6 and 12 months
Secondary	The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	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.	6 and 12 months
Secondary	QRS duration		baseline, 6, and 12 months