Aortic StenosisP-P-P-TAVINCT06499428
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
An observational study of Aortic Stenosis and Conduction Defect, Cardiac, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Conduction Defect, Cardiac
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2024to 10 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Data relating to all patients undergoing PM implantation will be collected in the days of hospitalization following TAVI surgery at our current institute (IRCCS Galeazzi Hospital - Sant'Ambrogio) between September 2022 and the closure of the study.
Who may be able to join
- PM implantation following TAVI surgery, during the same hospitalization
- Signature of informed consent
- Over the age of 18.
Who cannot join
- PM implantation prior to hospitalization for TAVI
- PM implantation during hospitalization different from the hospitalization for TAVI
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Tasso di Stimolazione Ventricolare Nel Follow-up Dei Pazienti Sottoposti ad Impianto di PM Post TAVI:Fattori Predittivi ed Evoluzione Clinica"
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).
Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates.
Read the detailed description
Aortic stenosis represents the most common valve defect in developed countries. Percutaneous transcatheter aortic valve implantation (TAVI) is now a first-line therapy for aortic stenosis.
The development of conduction blocks remains one of the most frequent complications of TAVI (3-26%), requiring the implantation of a permanent pacemaker (PM).
The damage caused to the conduction system during TAVI is the consequence of the anchoring of the prosthesis to the membranous septum.
There are several clinical, procedural and anatomical variables that correlate with a higher risk of permanent PM implantation post-TAVI, including age, pre-existence of BBDX, development of BBSX post TAVI, use of self-valves -expanding and implantation depth of the bioprosthesis.
Some anatomical variables, obtained from the CT study, appear to correlate with a greater risk of damage to the conduction system post-TAVI.
Recent studies have proven the importance of an accurate measurement of the length of the membranous septum, to design the depth of the bioprosthesis implant while minimizing the risk of damage to the conduction system.
The damage suffered by the conduction system, following the anchoring of the bioprosthesis, is largely inflammatory, and can, as such, be unpredictable in its evolution, and regress over time.
Recent data from the literature suggest that right ventricular stimulation by PM may, in the long term, worsen the prognosis of patients undergoing TAVI, and be associated with a higher rate of mortality from all causes and hospitalizations for decompensation, particularly when the percentage of PM stimulation is > 40%.
Furthermore, post-TAVI permanent PM implantation correlates with increased intensive care and hospitalization times, as well as healthcare costs.
Literature data regarding the evolution of post-TAVI conduction defects are still relatively lacking, and studies regarding the pacing percentage and its impact in post-TAVR patients are limited, especially in the long term, and based on small populations.
According to a recent meta-analysis, approximately half of the patients are not pacemaker dependent 1 year after implantation, furthermore the presence of pre-existing right bundle branch block and the use of self-expanding valves appear to be associated with a doubled risk of developing pacemaker dependence . .
The possibility and time of recovery of the conduction system post TAVI, and, consequently, the need for ventricular pacing, could also depend on some anatomical variables, including the length of the membranous septum and the presence of sub-valvular calcifications
- Conditions
- Aortic Stenosis, Conduction Defect, Cardiac
- Medical subject headings
- Aortic Valve Stenosis, Cardiac Conduction System Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
ventricular pacing rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start10 Apr 2024
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 67 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michela Tarascio, Principal investigator, IRCCS Galeazzi Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499428
- Sponsor's protocol ID
- P-P-P-TAVI
- Acronym
- P-P-P-TAVI
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Tasso di Stimolazione Ventricolare Nel Follow-up Dei Pazienti Sottoposti ad Impianto di PM Post TAVI:Fattori Predittivi ed Evoluzione Clinica"
- ClinicalTrials.gov ID
- NCT06499428
- Acronym / sponsor ID
- P-P-P-TAVI / P-P-P-TAVI
- Conditions
- Aortic Stenosis, Conduction Defect, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 12 Jul 2024 (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.
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).
Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates.
Detailed description
Aortic stenosis represents the most common valve defect in developed countries. Percutaneous transcatheter aortic valve implantation (TAVI) is now a first-line therapy for aortic stenosis.
The development of conduction blocks remains one of the most frequent complications of TAVI (3-26%), requiring the implantation of a permanent pacemaker (PM).
The damage caused to the conduction system during TAVI is the consequence of the anchoring of the prosthesis to the membranous septum.
There are several clinical, procedural and anatomical variables that correlate with a higher risk of permanent PM implantation post-TAVI, including age, pre-existence of BBDX, development of BBSX post TAVI, use of self-valves -expanding and implantation depth of the bioprosthesis.
Some anatomical variables, obtained from the CT study, appear to correlate with a greater risk of damage to the conduction system post-TAVI.
Recent studies have proven the importance of an accurate measurement of the length of the membranous septum, to design the depth of the bioprosthesis implant while minimizing the risk of damage to the conduction system.
The damage suffered by the conduction system, following the anchoring of the bioprosthesis, is largely inflammatory, and can, as such, be unpredictable in its evolution, and regress over time.
Recent data from the literature suggest that right ventricular stimulation by PM may, in the long term, worsen the prognosis of patients undergoing TAVI, and be associated with a higher rate of mortality from all causes and hospitalizations for decompensation, particularly when the percentage of PM stimulation is > 40%.
Furthermore, post-TAVI permanent PM implantation correlates with increased intensive care and hospitalization times, as well as healthcare costs.
Literature data regarding the evolution of post-TAVI conduction defects are still relatively lacking, and studies regarding the pacing percentage and its impact in post-TAVR patients are limited, especially in the long term, and based on small populations.
According to a recent meta-analysis, approximately half of the patients are not pacemaker dependent 1 year after implantation, furthermore the presence of pre-existing right bundle branch block and the use of self-expanding valves appear to be associated with a doubled risk of developing pacemaker dependence . .
The possibility and time of recovery of the conduction system post TAVI, and, consequently, the need for ventricular pacing, could also depend on some anatomical variables, including the length of the membranous septum and the presence of sub-valvular calcifications
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Data relating to all patients undergoing PM implantation will be collected in the days of hospitalization following TAVI surgery at our current institute (IRCCS Galeazzi Hospital - Sant'Ambrogio) between September 2022 and the closure of the study.
Key inclusion criteria (3 listed)
- PM implantation following TAVI surgery, during the same hospitalization
- Signature of informed consent
- Over the age of 18.
Key exclusion criteria (3 listed)
- PM implantation prior to hospitalization for TAVI
- PM implantation during hospitalization different from the hospitalization for TAVI
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ventricular pacing rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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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. This study is not recruiting at the moment.
Michela Tarascio principal investigator
IRCCS Galeazzi Sant'Ambrogio
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 Aortic Stenosis and Conduction Defect, Cardiac, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventricular pacing rate (time frame: 1 year). 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 7 Aug 2024.