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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05024279
Other study ID # 21-0575
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 6, 2021
Est. completion date April 2025

Study information

Verified date January 2023
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.


Description:

Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes. In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control). The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date April 2025
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis - LVEF =50% - Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden >20% - Signed informeed conseent to study participation Exclusion Criteria: - LVEF <50% - Expected pacing burden <20% - Pre-existing implanted cardiac device - Participation in a concurring interventional trial - age <18 years - Current preegnancy - life expectancy <6 months

Study Design


Intervention

Device:
Left bundle branch area pacing
Left bundle branch area pacing will be applied as established in the literature using commercially available equipment. In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed.
Right ventricular pacing
Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.

Locations

Country Name City State
Germany LMU Klinikum Munich BY

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Pacemaker-associated complications 3 months
Other Pacemaker-associated complications 12 months
Other Pacemaker-associated complications 24 months
Other procedural implantation success dichotomous yes / no basline
Other Implantation procedure duration baseline
Other Fluoroscopy duration baseline
Other Fluoroscopy dose baseline
Primary QRS duration QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads 3 months
Secondary QRS duration QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads 12 months
Secondary QRS duration QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads 24 months
Secondary Death of any cause 3 months
Secondary Death of any cause 12 months
Secondary Death of any cause 24 months
Secondary Death of cardio-vascular cause 3 months
Secondary Death of cardio-vascular cause 12 months
Secondary Death of cardio-vascular cause 24 months
Secondary Re-hospitalization due to heart failure 3 months
Secondary Re-hospitalization due to heart failure 12 months
Secondary Re-hospitalization due to heart failure 24 months
Secondary Change in left ventricular ejection fraction 3 months
Secondary Change in left ventricular ejection fraction 12 months
Secondary Change in left ventricular ejection fraction 24 months
Secondary Change in echocardiographic left ventricular enddiastolic diameter 3 months
Secondary Change in echocardiographic left ventricular enddiastolic diameter 12 months
Secondary Change in echocardiographic left ventricular enddiastolic diameter 24 months
Secondary Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency 3 months
Secondary Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency 12 months
Secondary Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency 24 months
Secondary Echocardiographic assessment of right ventricular ejection fraction 3 months
Secondary Echocardiographic assessment of right ventricular ejection fraction 12 months
Secondary Echocardiographic assessment of right ventricular ejection fraction 24 months
Secondary Change in New York heart failure classification status 3 months
Secondary Change in New York heart failure classification status 12 months
Secondary Change in New York heart failure classification status 24 months
Secondary Change in laboratory biomarkers NT-proBNP 3 months
Secondary Change in laboratory biomarkers NT-proBNP 12 months
Secondary Change in laboratory biomarkers NT-proBNP 24 months
Secondary Change in functional status by 6 minute walk 3 months
Secondary Change in functional status by 6 minute walk 12 months
Secondary Change in functional status by 6 minute walk 24 months
Secondary Change in EQ-5D quality of life 3 months
Secondary Change in EQ-5D quality of life 12 months
Secondary Change in EQ-5D quality of life 24 months
Secondary Occurence of arrhythmias 3 months
Secondary Occurence of arrhythmias 12 months
Secondary Occurence of arrhythmias 24 months
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