Incidence of Junctional RhythmJUNCTAVINCT06599008
Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.
An observational study of Incidence of Junctional Rhythm, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Transcatheter Aortic Valve Implantation (TAVI) aims to treat patients with symptomatic narrowing of the aorta by implanting an aortic bioprosthesis. This technique, which is currently highly developed, can lead to the appearance of cardiac conduction disorders following implantation, and in particular the presence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incidence of Junctional Rhythm
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Oct 2024to 1 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients implanted with aortic bioprosthesis [undergoing Transcatheter Aortic Valve Implantation (TAVI)] at Clermont-Ferrand University Hospital, between December 1st, 2023 and March 1st, 2025. Telemetric monitoring and daily electrocardiograms were used to identify junctional rhythms.
Who may be able to join
- Major patients who have undergone or are undergoing a TAVI procedure (since 01/12/2023) and who present a junctional rhythm.
Who cannot join
- Minor patients
- Patients already implanted with a pacemaker
- Atrial fibrillation
- Pregnant women.
- Patients under guardianship or legal protection
- Patients deprived of liberty
- Patients refusing to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0033473754963, promo_interne_drci@chu-clermontferrand.fr
Grégoire MASSOULLIE
About this study
Official title: Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
Transcatheter Aortic Valve Implantation (TAVI) aims to treat patients with symptomatic narrowing of the aorta by implanting an aortic bioprosthesis. This technique, which is currently highly developed, can lead to the appearance of cardiac conduction disorders following implantation, and in particular the presence of a junctional rhythm. Junctional rhythms are tachycardias involving a circuit between the atria and the ventricles (junction between the two compartments atrium and ventricle).
The goal of this observational study is to describe the incidence and pronostic of this rhythm disorder (junctional rhythm) following the TAVI procedure.
Read the detailed description
Monocentric observational study including all patients implanted with aortic bioprosthesis [undergoing Transcatheter Aortic Valve Implantation (TAVI)] at Clermont-Ferrand University Hospital, between December 1st, 2023 and March 1st, 2025. Telemetric monitoring and daily electrocardiograms were used to identify junctional rhythms. The primary endpoint was pacemaker (PM) implantation between day 0 and day 30 after TAVI. Patients with a junctional rhythm at the time of hospitalization were recalled to find out whether they had benefited from PM implantation within 30 days after the TAVI procedure.
- Conditions
- Incidence of Junctional Rhythm
- Keywords
- Transcatheter Aortic Valve Implantation, Junctional rhythm
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of junctional rhythm during hospitalization after TAVI procedure.
The primary endpoint was pacemaker (PM) implantation between day 0 and day 30 after TAVI. Patients with a junctional rhythm at the time of hospitalization were recalled to find out whether they had benefited from PM implantation within 30 days after the TAVI procedure.
Measured: 30 days post TAVI procedure
Secondary outcomes (2)
Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure.
Need for pacemaker implantation between D0 and D30, following the TAVI procedure.
Measured: 30 days post TAVI procedure
Investigate the association between the presence of a junctional rhythm following TAVI procedure and all-cause or cardiovascular mortality, rehospitalization, and heart failure.
Assessment of the prognosis of junctional rhythms: collection of all-cause mortality, cardiovascular mortality, presence of syncope, conduction disorder on Holter ECG, rehospitalizations, occurrence of heart failure at day 30 post TAVI.
Measured: 30 days post TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Oct 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Junctional RhythmStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599008
- Sponsor's protocol ID
- RNI 2024 MASSOULLIE
- Other IDs
- 2024-A01132-45, 24.03051.000665
- Acronym
- JUNCTAVI
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
- ClinicalTrials.gov ID
- NCT06599008
- Acronym / sponsor ID
- JUNCTAVI / RNI 2024 MASSOULLIE
- Conditions
- Incidence of Junctional Rhythm
- Keywords
- Transcatheter Aortic Valve Implantation, Junctional rhythm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Sep 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.
Transcatheter Aortic Valve Implantation (TAVI) aims to treat patients with symptomatic narrowing of the aorta by implanting an aortic bioprosthesis. This technique, which is currently highly developed, can lead to the appearance of cardiac conduction disorders following implantation, and in particular the presence of a junctional rhythm. Junctional rhythms are tachycardias involving a circuit between the atria and the ventricles (junction between the two compartments atrium and ventricle).
The goal of this observational study is to describe the incidence and pronostic of this rhythm disorder (junctional rhythm) following the TAVI procedure.
Detailed description
Monocentric observational study including all patients implanted with aortic bioprosthesis [undergoing Transcatheter Aortic Valve Implantation (TAVI)] at Clermont-Ferrand University Hospital, between December 1st, 2023 and March 1st, 2025. Telemetric monitoring and daily electrocardiograms were used to identify junctional rhythms. The primary endpoint was pacemaker (PM) implantation between day 0 and day 30 after TAVI. Patients with a junctional rhythm at the time of hospitalization were recalled to find out whether they had benefited from PM implantation within 30 days after the TAVI procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients implanted with aortic bioprosthesis [undergoing Transcatheter Aortic Valve Implantation (TAVI)] at Clermont-Ferrand University Hospital, between December 1st, 2023 and March 1st, 2025. Telemetric monitoring and daily electrocardiograms were used to identify junctional rhythms.
Key inclusion criteria (1 listed)
- Major patients who have undergone or are undergoing a TAVI procedure (since 01/12/2023) and who present a junctional rhythm.
Key exclusion criteria (7 listed)
- Minor patients
- Patients already implanted with a pacemaker
- Atrial fibrillation
- Pregnant women.
- Patients under guardianship or legal protection
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
The occurrence of junctional rhythm during hospitalization after TAVI procedure.
Time frame: 30 days post TAVI procedure
The primary endpoint was pacemaker (PM) implantation between day 0 and day 30 after TAVI. Patients with a junctional rhythm at the time of hospitalization were recalled to find out whether they had benefited from PM implantation within 30 days after the TAVI procedure.
2 secondary outcomes
Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure.
Time frame: 30 days post TAVI procedure
Investigate the association between the presence of a junctional rhythm following TAVI procedure and all-cause or cardiovascular mortality, rehospitalization, and heart failure.
Time frame: 30 days post TAVI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence of Junctional Rhythm, run by University Hospital, Clermont-Ferrand at 2 sites 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 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 473 754 963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of junctional rhythm during hospitalization after TAVI procedure. (time frame: 30 days post TAVI procedure). 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 19 Sep 2024.