Conventional Versus Left Bundle Branch Pacing in TAVI

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05895097

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Heart Failure Pacemaker-Induced Cardiomyopathy Transcatheter Aortic Valve Implantation	Device: Left bundle branch pacemaker Device: Conventional pacing	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jun 15, 2025

Anticipated Study Completion Date :

Jun 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional pacing	Device: Conventional pacing Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %
Experimental: LBB pacing	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.

Arm

Intervention/Treatment

Active Comparator: Conventional pacing

Device: Conventional pacing

Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %

Experimental: LBB pacing

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.

Outcome Measures

Primary Outcome Measures

Left ventricular ejection fraction [12 months]

Secondary Outcome Measures

Left ventricular systolic diameter [12 months]
Left ventricular diastolic diameter [12 months]
Global work index [12 months]
Amount of myocardial work performed by the left ventricle during systole.
Global constructive work [12 months]
Positive work performed in systole + negative work performed in isovolumetric relaxation
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]
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]
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.
QRS duration [baseline, 6, and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klemen Steblovnik, Principal Investigator, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT05895097

Other Study ID Numbers:

PACE TAVI

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Klemen Steblovnik, Principal Investigator, University Medical Centre Ljubljana

Transcatheter Aortic Valve Implantation

Left bundle branch pacing

Additional relevant MeSH terms:

Cardiomyopathies

Aortic Valve Stenosis

Study Results

No Results Posted as of Jun 8, 2023