Aortic Valve StenosisPACE-TAVINCT05278585
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
An observational study of Aortic Valve Stenosis, run by AZ Sint-Jan AV at 12 sites in Belgium.
Trial summary
The current observational registry aims to evaluate in patients undergoing TAVI implantation: 1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure, 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- RAP TAVI
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 12 sitesBelgium
- Study dates
- 1 Sep 2022to Jun 2024
- How long will I take part?
- 1 Month
- 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: 500 patients in sinus rhythm undergoing TAVI
Who may be able to join
- All patients in sinus rhythm with TAVI
Who cannot join
- Patients in atrial fibrillation at the time of the implantation
- Patients with pre-existent pacemaker
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Belgium12 sites, 12 recruiting
- Recruiting
Algemeen Stedelijk Ziekenhuis Aalst
Aalst
An Roets
Liesbeth Rosseel, MD
- Recruiting
OLV Aalst
Aalst
Steve Aerts, Cardio.studie.aalst@olvz-aalst.be
Marc Vanderheyden, MD
- Recruiting
ZNA Middelheim
Antwerp
Petra Vanextergem, studies.cardio@zna.be
Benjamin Scott, MD
- Recruiting
AZ Sint Jan
Bruges, 8000
Ian Buysschaert, MD PhD, +32 50 45 26 70, ian.buysschaert@azsintjan.be
Ian Buysschaert, MD, PhD
- Recruiting
CHU Charleroi-Chimay
Charleroi
Asuncion Conde Y Bolado, sncardio@humani.be
Adel Aminian, MD
- Recruiting
Grand Hôpital de Charleroi
Charleroi
Amandine Jourdan
Frédéric De Vroey, MD
- Recruiting
Ziekenhuis Oost-Limburg
Genk
Lieke Peeters
Bert Ferdinande, MD
- Recruiting
UZ Brussel
Jette
Ingrid Lemoine
Bert Vandeloo, MD
- Recruiting
UZ Leuven
Leuven
Marina Claes
Tom Adriaenssens, MD, PhD
- Recruiting
Citadelle Hospital
Liège
Sophie Jacquet, rc-cardio@citadelle.be
Charles Pirlet, MD
- Recruiting
Clinique Saint-Luc Bouge
Namur
Soon-Ja Collard
François Simon, MD
- Recruiting
AZ Delta
Roeselare
Els Vancayseele
Francis Stammen, MD, PhD
About this study
Official title: Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
The current observational registry aims to evaluate in patients undergoing TAVI implantation:
- the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
- baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
- peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
Read the detailed description
The persistent growth in transcatheter aortic valve implantation (TAVI) calls for optimized early discharge programs to handle the increasing patient load. While access site bleeding and stroke rate have decreased with improved technologies and operators' experience, acquired conduction abnormalities necessitating prolonged rhythm-monitoring and permanent pacemaker (PPM) implantation have remained largely unchanged, and even up to 39.9% for some TAVI platforms. Prompt identification of patients necessitating PPM implantation leads to optimal patient care and use of resources. Conversely, prompt identification of patients with low -to no- risk for PPM post TAVI shortens their hospitalization and facilitates early and safe discharge.
Several baseline characteristics such as age, preexistent right bundle branch block (RBBB) and the use of self-expanding valves are associated with post-TAVI PPM implantation, but more practical and clinically more relevant parameters are needed with high negative and positive predictive values that could support clinical decision-making.
En passant rapid atrial pacing (RAP) immediately following TAVI has recently been reported to be a valuable tool in PPM risk stratification. The absence of Wenckebach phenomena post implantation at RAP up to 120/' has a negative predictive value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data). This technique improves our clinical assessment and identification of low-risk patients for PPM suitable for safe early discharge, as well as high-risk patients requiring further rhythm monitoring and eventual PPM implantation.
The current observational registry aims to evaluate in patients undergoing TAVI implantation:
- the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
- baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
- peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
- Conditions
- Aortic Valve Stenosis
- Being tested
- RAP TAVI
- 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.
RAP TAVIProcedure or surgery
All patients undergoing TAVI with no pre-existing pacemaker and in sinus rhythm at the time of the procedure will receive RAP by placing the temporary wire in the right atrium
| Study group | Role | What they receive |
|---|---|---|
| RAP TAVI group | All patients in sinus rhythm with TAVI Receives: Procedure: RAP TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative predictive value of RAP for PPM implantation post TAVI
Measured: 1 month after TAVI
Permanent pacemaker implantation
Measured: 1 month after TAVI
New conduction abnormalities
Measured: within 1 week after TAVI
Secondary outcomes (6)
Duration of hospitalization
Measured: 1 month after TAVI
Echocardiographic changes
Measured: 1 month after TAVI
Stroke
Measured: 1 month after TAVI
Major vascular bleeding
Measured: 1 month after TAVI
New pericardial effusion
Measured: 1 month after TAVI
All-cause mortality
Measured: 1 month after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Sep 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Buysschaert, MD PhD, AZ Sint-Jan AV
- Investigators
- Ian Buysschaert, MD, PhD, Principal investigator, AZ Sint Jan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278585
- Sponsor's protocol ID
- version 1 21/02/2022
- Acronym
- PACE-TAVI
- Status last verified
- Nov 2023
- First submitted
- 4 Mar 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Cock E, Adriaenssens T, Stammen F, Vanderheyden M, Dubois C, Vanhaverbeke M, Ferdinande B, Pirlet C, Simon F, Vandeloo B, Lesizza P, Rosseel L, Aminian A, Scott B, De Vroey F, Christiaen E, le Polain de Waroux JB, Van der Heyden J, Buysschaert I. Rapid Atrial Pacing-Induced Wenckebach Atrioventricular Block: A Poor Predictor of Permanent Pacemaker Need Post-TAVR. Circ Cardiovasc Interv. 2026 May;19(5):e016145. doi: 10.1161/CIRCINTERVENTIONS.125.016145. Epub 2026 Mar 26.
PubMed 41884902
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
- ClinicalTrials.gov ID
- NCT05278585
- Acronym / sponsor ID
- PACE-TAVI / version 1 21/02/2022
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 14 Mar 2022 (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 current observational registry aims to evaluate in patients undergoing TAVI implantation:
- the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
- baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
- peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
Detailed description
The persistent growth in transcatheter aortic valve implantation (TAVI) calls for optimized early discharge programs to handle the increasing patient load. While access site bleeding and stroke rate have decreased with improved technologies and operators' experience, acquired conduction abnormalities necessitating prolonged rhythm-monitoring and permanent pacemaker (PPM) implantation have remained largely unchanged, and even up to 39.9% for some TAVI platforms. Prompt identification of patients necessitating PPM implantation leads to optimal patient care and use of resources. Conversely, prompt identification of patients with low -to no- risk for PPM post TAVI shortens their hospitalization and facilitates early and safe discharge.
Several baseline characteristics such as age, preexistent right bundle branch block (RBBB) and the use of self-expanding valves are associated with post-TAVI PPM implantation, but more practical and clinically more relevant parameters are needed with high negative and positive predictive values that could support clinical decision-making.
En passant rapid atrial pacing (RAP) immediately following TAVI has recently been reported to be a valuable tool in PPM risk stratification. The absence of Wenckebach phenomena post implantation at RAP up to 120/' has a negative predictive value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data). This technique improves our clinical assessment and identification of low-risk patients for PPM suitable for safe early discharge, as well as high-risk patients requiring further rhythm monitoring and eventual PPM implantation.
The current observational registry aims to evaluate in patients undergoing TAVI implantation:
- the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
- baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
- peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAP TAVI group | – | Procedure: RAP TAVIAll patients in sinus rhythm with TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients in sinus rhythm undergoing TAVI
Key inclusion criteria (1 listed)
- All patients in sinus rhythm with TAVI
Key exclusion criteria (2 listed)
- Patients in atrial fibrillation at the time of the implantation
- Patients with pre-existent pacemaker
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 |
|---|---|---|
| RAP TAVIAll patients undergoing TAVI with no pre-existing pacemaker and in sinus rhythm at the time of the procedure will receive RAP by placing the temporary wire in the right atrium | Procedure or surgery | RAP TAVI group |
Primary outcome
Positive and negative predictive value of RAP for PPM implantation post TAVI
Time frame: 1 month after TAVI
Permanent pacemaker implantation
Time frame: 1 month after TAVI
New conduction abnormalities
Time frame: within 1 week after TAVI
6 secondary outcomes
Duration of hospitalization
Time frame: 1 month after TAVI
Echocardiographic changes
Time frame: 1 month after TAVI
Stroke
Time frame: 1 month after TAVI
Major vascular bleeding
Time frame: 1 month after TAVI
New pericardial effusion
Time frame: 1 month after TAVI
All-cause mortality
Time frame: 1 month after TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41884902De Cock E, Adriaenssens T, Stammen F, Vanderheyden M, Dubois C, Vanhaverbeke M, Ferdinande B, Pirlet C, Simon F, Vandeloo B, Lesizza P, Rosseel L, Aminian A, Scott B, De Vroey F, Christiaen E, le Polain de Waroux JB, Van der Heyden J, Buysschaert I. Rapid Atrial Pacing-Induced Wenckebach Atrioventricular Block: A Poor Predictor of Permanent Pacemaker Need Post-TAVR. Circ Cardiovasc Interv. 2026 May;19(5):e016145. doi: 10.1161/CIRCINTERVENTIONS.125.016145. Epub 2026 Mar 26.
Related trials for Aortic Valve Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Ian Buysschaert, MD, PhD principal investigator
AZ Sint Jan
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by AZ Sint-Jan AV at 12 sites in Belgium.
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 2 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. 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 Ian Buysschaert, MD, PhD (+32050452670, ian.buysschaert@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative predictive value of RAP for PPM implantation post TAVI (time frame: 1 month after TAVI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278585, which also lists 1 linked publication.
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 29 Nov 2023.