An interventional study of Transcatheter Aortic Valve Implantation in Left Bundle-Branch Block, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.
This is a prospective, multicentric, randomized in parallel group, controlled, open labelled clinical study.
After written consent will be obtained, included patients will be randomized into two groups according to a 1:1 ratio:
Patients will be followed-up according to current practice.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 360 is above the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :
Exclusion Criteria:
During in-hospital monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring.
Procedure: Transcatheter Aortic Valve Implantation
In this group, Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms.
Procedure: Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously
Alive status with appropriate Pacemaker implantation/non-implantation
The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization. * Appropriate Pacemaker non-implantation: \- Absence of syncope or sudden cardiac death in a non-implanted patient * Appropriate Pacemaker implantation: * Documented indisputable criteria for Pacemaker implantation * Absence of syncope or sudden cardiac death * Absence of upgrading procedure
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for May 2027, 30 months after the start.
Of 32 interventional studies with no phase under Bundle-Branch Block, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 61. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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