Tricuspid Regurgitation (TR)NCT07043465
Ambulant Monitoring to Detect Hemodynamic and Electrical Impact of Severe Tricuspid Valve Regurgitation
A study testing 14 days ambulatory rhythm monitoring in people with Tricuspid Regurgitation (TR), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This exploratory study aims to study the feasibility to detect early signs of disease progression in patients with severe TVR (grade ≥3/4) by monitoring electrical cardiac activity and correlating it with echocardiographic findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- 14 days ambulatory rhythm monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tricuspid valve regurgitation (TVR) grade ≥3/4 documented on Colour Doppler during routine transthoracic echocardiography
- Normal sinus rhythm
- Dutch speaking
Who cannot join
- History of cardiac surgery
- Abnormal rhythm at baseline visit
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory study aims to study the feasibility to detect early signs of disease progression in patients with severe TVR (grade ≥3/4) by monitoring electrical cardiac activity and correlating it with echocardiographic findings. The Byteflies monitoring device will be used for continuous 14-day outpatient ECG tracking. Transthoracic echocardiography will assess structural and pressure changes in the heart and liver. The goal is to improve early detection of right heart failure and hepatic congestion.
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- 14 days ambulatory rhythm monitoring
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 days ambulatory rhythm monitoringDiagnostic test
14 days ambulatory rhythm monitoring using Byteflies
| Study group | Role | What they receive |
|---|---|---|
| 14 days ambulatory rhtyhm monitoring | Experimental | 14 days ambulatory rhtyhm monitoring to detect electrical instability Receives: Diagnostic Test: 14 days ambulatory rhythm monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial electrical instability
Burden (expressed in % of total number of beats) of isolated atrial extrasystoles, runs of atrial tachycardie (less than 30 seconds), and sustained atrial arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.
Measured: 14 days
Ventricular electrical instability
Burden (expressed in % of total number of beats) of isolated ventricular extrasystoles, runs of ventricular tachycardie (less than 30 seconds), and sustained ventricular arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.
Measured: 14 days
Secondary outcomes (2)
Bradycardia
Prevalence (%) of bradycardia events on 14 day rhythm monitoring defined as any occurence of ventricular rhythms <30 beats per minute or high-degree AV block. These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.
Measured: 14 days
Adverse events associated with rhythm monitoring
Prevalence (%) of any interruption in 14 days rhythm monitoring due to adverse events with the Byteflies monitoring patch (skin rash, allergic reactions,...)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Feb 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043465
- Sponsor's protocol ID
- S68180
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulant Monitoring to Detect Hemodynamic and Electrical Impact of Severe Tricuspid Valve Regurgitation
- ClinicalTrials.gov ID
- NCT07043465
- Acronym / sponsor ID
- S68180
- Conditions
- Tricuspid Regurgitation (TR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Jun 2025 (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.
This exploratory study aims to study the feasibility to detect early signs of disease progression in patients with severe TVR (grade ≥3/4) by monitoring electrical cardiac activity and correlating it with echocardiographic findings. The Byteflies monitoring device will be used for continuous 14-day outpatient ECG tracking. Transthoracic echocardiography will assess structural and pressure changes in the heart and liver. The goal is to improve early detection of right heart failure and hepatic congestion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14 days ambulatory rhtyhm monitoring | Experimental | Diagnostic Test: 14 days ambulatory rhythm monitoring14 days ambulatory rhtyhm monitoring to detect electrical instability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tricuspid valve regurgitation (TVR) grade ≥3/4 documented on Colour Doppler during routine transthoracic echocardiography
- Normal sinus rhythm
- Dutch speaking
Key exclusion criteria (3 listed)
- History of cardiac surgery
- Abnormal rhythm at baseline visit
- Age <18 years
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 |
|---|---|---|
| 14 days ambulatory rhythm monitoring14 days ambulatory rhythm monitoring using Byteflies | Diagnostic test | 14 days ambulatory rhtyhm monitoring |
Primary outcome
Atrial electrical instability
Time frame: 14 days
Burden (expressed in % of total number of beats) of isolated atrial extrasystoles, runs of atrial tachycardie (less than 30 seconds), and sustained atrial arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.
Ventricular electrical instability
Time frame: 14 days
Burden (expressed in % of total number of beats) of isolated ventricular extrasystoles, runs of ventricular tachycardie (less than 30 seconds), and sustained ventricular arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.
2 secondary outcomes
Bradycardia
Time frame: 14 days
Adverse events associated with rhythm monitoring
Time frame: 14 days
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 29 Jun 2025.
- Individual participant dataSharing planned: No
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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 14 days ambulatory rhythm monitoring in people with Tricuspid Regurgitation (TR), run by Universitaire Ziekenhuizen KU Leuven at 1 site 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 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: finished, as of the sponsor's last update on 29 Jun 2025. 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 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?
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?
Atrial electrical instability (time frame: 14 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 29 Jun 2025.