Aortic Valve StenosisNCT03561805
Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation
A study testing ECG monitoring in people with Aortic Valve Stenosis and Arrythmia, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis, Arrythmia
- What is being tested?
- ECG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Jan 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.
Who cannot join
- Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
- Prior permanent pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study
Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.
Read the detailed description
This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.
- Conditions
- Aortic Valve Stenosis, Arrythmia
- Being tested
- ECG monitoring
- Keywords
- TAVI, ECG monitoring
- Medical subject headings
- Aortic Valve Stenosis, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoringDevice
Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure
| Study group | Role | What they receive |
|---|---|---|
| Prolonged continuous ECG monitoring | Other | Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. Receives: Device: ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmic events
Incidence and type of arrhythmic events
Measured: Within 3 months prior to the TAVI procedure
Therapeutic changes
incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure
Measured: Within 3 months prior to the TAVI procedure
Secondary outcomes (7)
Atrial fibrillation
incidence of atrial fibrillation
Measured: Within 3 months prior to the TAVI procedure
Atrial fibrillation
duration of atrial fibrillation
Measured: Within 3 months prior to the TAVI procedure
Atrioventricular block
incidence of advanced atrioventricular block
Measured: Within 3 months prior to the TAVI procedure
Severe bradycardia
incidence of severe bradycardia
Measured: Within 3 months prior to the TAVI procedure
Left bundle branch block
incidence of left bundle branch block
Measured: Within 3 months prior to the TAVI procedure
Permanent pacemaker
percentage of patients with an indication of permanent pacemaker
Measured: Within 3 months prior to the TAVI procedure
Anticoagulation therapy
percentage of patients with an indication for anticoagulation therapy
Measured: Within 3 months prior to the 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 Jun 2018
- Study start1 Jun 2017
- Primary completion31 Jan 2020
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561805
- Sponsor's protocol ID
- PARE
- Status last verified
- Nov 2026
- First submitted
- 13 Apr 2018
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study
- ClinicalTrials.gov ID
- NCT03561805
- Acronym / sponsor ID
- PARE
- Conditions
- Aortic Valve Stenosis, Arrythmia
- Keywords
- TAVI, ECG monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 19 Jun 2018 (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.
Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.
Detailed description
This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged continuous ECG monitoring | Other | Device: ECG monitoringPatients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.
Key exclusion criteria (2 listed)
- Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
- Prior permanent 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 |
|---|---|---|
| ECG monitoringProlonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure | Device | Prolonged continuous ECG monitoring |
Primary outcome
Arrhythmic events
Time frame: Within 3 months prior to the TAVI procedure
Incidence and type of arrhythmic events
Therapeutic changes
Time frame: Within 3 months prior to the TAVI procedure
incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure
7 secondary outcomes
Atrial fibrillation
Time frame: Within 3 months prior to the TAVI procedure
Atrial fibrillation
Time frame: Within 3 months prior to the TAVI procedure
Atrioventricular block
Time frame: Within 3 months prior to the TAVI procedure
Severe bradycardia
Time frame: Within 3 months prior to the TAVI procedure
Left bundle branch block
Time frame: Within 3 months prior to the TAVI procedure
Permanent pacemaker
Time frame: Within 3 months prior to the TAVI procedure
Anticoagulation therapy
Time frame: Within 3 months prior to the TAVI procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG monitoring in people with Aortic Valve Stenosis and Arrythmia, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arrhythmic events (time frame: Within 3 months prior to the TAVI procedure). 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 4 Nov 2026.