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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05895097
Other study ID # PACE TAVI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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