Patients Above 18 YearsPACETAVINCT06756282
One Year Pacing Dependency After TAVR
An observational study of Patients Above 18 Years and Patient Discharge, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Above 18 Years, Patient Discharge, Pacing Therapy
- What is being tested?
- Pacemaker and defibrillator
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2024to 13 Oct 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have TAVR and who are considered to need permanent pacemaker implantation before hospital discharge relating to high degree, symptomatic or not, conductive disorders
Who may be able to join
- all patients who need a permanent pacemaker implantation after TAVR
Who cannot join
- Patients who have already a pace maker before TAVR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Florence Leclercq, Professor
About this study
Official title: Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study.
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not found to be dependent at subsequent follow-up. This study aims to evaluate a cohort of patients permanently implanted with a pacemaker post-TAVR for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the evaluation of the prevalence of effective stimulation 3 months after implantation of the pace maker , description of the types of conductive disorders associated with atrial and/or ventricular stimulation, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency. The objective is to better rationalize indication of permanent stimulation after TAVI
Read the detailed description
A number of independent predictors have been found for long-term pacemaker dependence after TAVR that included a pre-existing RBBB, first-degree atrioventricular block, left anterior hemiblock, porcelain aorta, and implantation depth of the prosthesis However, indications for definitive cardiac stimulation after TAVR remain controversial excepted in case of complete or persistent high-grade BAV. The recommendations are particularly imprecise regarding intraventricular conductive disorders (LBBB++) and AVB 1.
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
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Being tested
- Pacemaker and defibrillator
- Keywords
- transcatheter aortic valve replacement (TAVR), permanent pacing, conductive disorders, pacing dependency
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker and defibrillatorProcedure or surgery
only patients with pacemaker implantation will be evaluated in the study
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Pacemaker and defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
pacing dependency at 1 year follow-up
pacing dependency is defined:
- escape QRS rhythm < 30 bpm
- High degree atrioventricular block (paroxysmal or permanent)
- Atrial fibrillation with escape rhythm <40/min
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start13 Nov 2024
- Primary completionOct 2025 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Above 18 YearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756282
- Sponsor's protocol ID
- 2024-09-137
- Acronym
- PACETAVI
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study.
- ClinicalTrials.gov ID
- NCT06756282
- Acronym / sponsor ID
- PACETAVI / 2024-09-137
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Keywords
- transcatheter aortic valve replacement (TAVR), permanent pacing, conductive disorders, pacing dependency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Biotronik France
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not found to be dependent at subsequent follow-up. This study aims to evaluate a cohort of patients permanently implanted with a pacemaker post-TAVR for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the evaluation of the prevalence of effective stimulation 3 months after implantation of the pace maker , description of the types of conductive disorders associated with atrial and/or ventricular stimulation, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency. The objective is to better rationalize indication of permanent stimulation after TAVI
Detailed description
A number of independent predictors have been found for long-term pacemaker dependence after TAVR that included a pre-existing RBBB, first-degree atrioventricular block, left anterior hemiblock, porcelain aorta, and implantation depth of the prosthesis However, indications for definitive cardiac stimulation after TAVR remain controversial excepted in case of complete or persistent high-grade BAV. The recommendations are particularly imprecise regarding intraventricular conductive disorders (LBBB++) and AVB 1.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who need permanent pace maker implantation after TAVR | – | Procedure: Pacemaker and defibrillatorpatients 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have TAVR and who are considered to need permanent pacemaker implantation before hospital discharge relating to high degree, symptomatic or not, conductive disorders
Key inclusion criteria (1 listed)
- all patients who need a permanent pacemaker implantation after TAVR
Key exclusion criteria (1 listed)
- Patients who have already a pace maker before TAVR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker and defibrillatoronly patients with pacemaker implantation will be evaluated in the study | Procedure or surgery | Patients who need permanent pace maker implantation after TAVR |
Primary outcome
pacing dependency at 1 year follow-up
Time frame: 6 months
pacing dependency is defined: 1. escape QRS rhythm < 30 bpm 2. High degree atrioventricular block (paroxysmal or permanent) 3. Atrial fibrillation with escape rhythm <40/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Above 18 Years and Patient Discharge, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence Leclercq, PUPH (0467336189, f-leclercq@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pacing dependency at 1 year follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.