Aortic StenosisTAVI-REVERSENCT06481137
Reversibility of Cardiac Conduction Disturbances Following TAVI
A study testing Electrophysiological study (EP study) and ePatch (extended Holter Monitoring) in people with Aortic Stenosis and Transcatheter Aortic Valve Implantation, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.
Trial summary
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
- What is being tested?
- Electrophysiological study (EP study) and ePatch (extended Holter Monitoring)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):
- De novo LBBB with QRS complex >150ms and/or PR interval ≥240ms.
- QRS widening or post-procedural PR lengthening > 20ms in patients with baseline ECG-CDs.
Who cannot join
- Patients with previous pacemaker or implantable defibrillator.
- Patients with baseline complete right bundle branch block.
- Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
- Valve-in-valve procedures.
- TAVI procedures in patients with severe aortic insufficiency.
- Inability to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08097
Hospital Universitari de Bellvitge, +342607500 ext. 7539, uac@bellvitgehospital.cat
Guillem Muntané Carol, MD, PhD
About this study
Official title: InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.
In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.
In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.
- Being tested
- Electrophysiological study (EP study), ePatch (extended Holter Monitoring)
- Keywords
- Aortic stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
- 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.
Electrophysiological study (EP study)Diagnostic test
Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI.
ePatch (extended Holter Monitoring)Diagnostic test
Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI
| Study group | Role | What they receive |
|---|---|---|
| Positive initial (3-7 days following TAVI) electrophysiological study (EP+) | Experimental | Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI. Receives: Diagnostic Test: Electrophysiological study (EP study); Diagnostic Test: ePatch (extended Holter Monitoring) |
| Negative initial (3-7 days following TAVI) electrophysiological study (EP-) | Other | Continuous ECG monitoring during 4 weeks. Receives: Diagnostic Test: ePatch (extended Holter Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of retrogradation
- Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
Measured: 30 days
Need for cardiac pacing (incidence of advanced atrioventricular block)
- Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start17 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Hospital Universitario La Paz, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital Universitario A Coruna Spain, Hospital Clinico Universitario de Santiago, Hospital Universitario Central de Asturias, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valladolid
- Responsible party
- Principal investigator, Guillem Muntané Carol, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481137
- Sponsor's protocol ID
- ICPS025/24
- Other IDs
- PI23/00310
- Acronym
- TAVI-REVERSE
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study procotol and ICF will be shared trough PI request during the duration of the study
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
- ClinicalTrials.gov ID
- NCT06481137
- Acronym / sponsor ID
- TAVI-REVERSE / ICPS025/24
- Keywords
- Aortic stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Hospital Universitario La Paz, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital Universitario A Coruna Spain, Hospital Clinico Universitario de Santiago, Hospital Universitario Central de Asturias, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valladolid
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 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 management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.
In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.
In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive initial (3-7 days following TAVI) electrophysiological study (EP+) | Experimental | Diagnostic Test: Electrophysiological study (EP study), Diagnostic Test: ePatch (extended Holter Monitoring)Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI. |
| Negative initial (3-7 days following TAVI) electrophysiological study (EP-) | Other | Diagnostic Test: ePatch (extended Holter Monitoring)Continuous ECG monitoring during 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):
- De novo LBBB with QRS complex >150ms and/or PR interval ≥240ms.
- QRS widening or post-procedural PR lengthening > 20ms in patients with baseline ECG-CDs.
Key exclusion criteria (6 listed)
- Patients with previous pacemaker or implantable defibrillator.
- Patients with baseline complete right bundle branch block.
- Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
- Valve-in-valve procedures.
- TAVI procedures in patients with severe aortic insufficiency.
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 |
|---|---|---|
| Electrophysiological study (EP study)Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI. | Diagnostic test | Positive initial (3-7 days following TAVI) electrophysiological study (EP+) |
| ePatch (extended Holter Monitoring)Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI | Diagnostic test | Negative initial (3-7 days following TAVI) electrophysiological study (EP-), Positive initial (3-7 days following TAVI) electrophysiological study (EP+) |
Primary outcome
Incidence of retrogradation
Time frame: 30 days
1. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
Need for cardiac pacing (incidence of advanced atrioventricular block)
Time frame: 30 days
2. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
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 1 Jul 2024.
- Individual participant dataSharing planned: Yes. Study procotol and ICF will be shared trough PI request during the duration of the study
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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?
A study testing Electrophysiological study (EP study) and ePatch (extended Holter Monitoring) in people with Aortic Stenosis and Transcatheter Aortic Valve Implantation, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.
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 6 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 1 Jul 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 Spain. 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 Guillem Muntané Carol, MD, PhD (+342607500 ext. 7539, gmuntanec@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of retrogradation (time frame: 30 days). The study lists 2 primary outcomes in all. 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 1 Jul 2024.