Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
90 participants
OBSERVATIONAL
2024-11-13
2027-10-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
NCT06499428
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
NCT01801098
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
NCT02700633
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
NCT02994667
STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI
NCT03338582
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Regarding the potential occurrence of more serious and delayed conductive disorders, the implantation of a pacemaker can sometimes be proposed to limit the duration of hospitalization in intensive care or ECG monitoring. The pacemaker implantation rate therefore probably does not reflect the true incidence of high-grade conductive disorders after TAVI because this rate varies greatly depending on the center, the indications for definitive stimulation still remain unclear, the rapid implantation times for a conductive disorder which risks getting worse (LBBG++) in a context of ever-shorter hospitalization periods can artificially increase the number of implantations.
the main objective of our study is therefore to evaluate a cohort of patients permanently implanted post-TAVR in our center since September 2023 for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the prevalence of effective stimulation 3 months after implantation of the definitive pace maker , description of the types of conductive disorders associated with pacing dependency at follow-up, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency Describe serious clinical events at 3 months and 12 months (mortality, stroke, heart failure, rehospitalization for cardiac causes, complications related to the pace maker) Describe the profile of stimulation or non-stimulus dependent patients
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients who need permanent pace maker implantation after TAVR
patients with high degree conductive disorders after TAVR who required pacemaker implantation before discharge the study will evaluated pacing dependency at one year (main objective) and the profile of patients with pacing dependency (type of initial conductive disorder, clinical characteristics)
Pacemaker and defibrillator
only patients with pacemaker implantation will be evaluated in the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pacemaker and defibrillator
only patients with pacemaker implantation will be evaluated in the study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik France
INDUSTRY
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Montpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Florence Leclercq, Professor
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-09-137
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.