Atrial Fibrillation (AF)TRICUSPID-AFNCT07617974
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
An observational study of Atrial Fibrillation (AF) and Tricuspid Regurgitation (TR), run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2026to 31 May 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suitable for enrolment in the present study are those with paroxysmal or persistent atrial fibrillation (AF) undergoing transthoracic echocardiography (TTE) prior to AF ablation and will be study group. The study group will be compared with the following control groups: a) patients with structurally normal hearts and no history of AF; b) patients with ≥ moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.
Who may be able to join
- Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.
- Eligible for enrollment in the control group will be:
- all consecutive patients with structurally normal hearts and no history of AF or;
- moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.
Who cannot join
- Moderate or greater TR assessed using a multiparametric approach;
- Arrhythmias other than AF;
- Prior AF ablations;
- Rapid ventricular response (average HR >110 bpm) during baseline TTE;
- Inadequate image quality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino; IRCCS
Milan, Milan, 20133
Chiara Centenaro, 0258002031, chiara.centenaro@cardiologicomonzino.it
About this study
Official title: Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.
Read the detailed description
Patients with paroxysmal or persistent AF undergoing transthoracic echocardiography (TTE) prior to AF ablation will be enrolled and will undergo repeat TTE at 1-year follow-up. The echocardiographic assessment will include standard measurements, right atrial and right ventricular strain analysis, and 3D acquisitions of the tricuspid valve (and mitral valve, if feasible). Tricuspid valve geometry will be analyzed using an AI-powered 3D quantification tool. AF burden will be assessed through serial Holter ECG monitoring at baseline, 3, and 12 months.
The primary endpoint is the difference in 3D tricuspid annular geometry between patients with paroxysmal and persistent AF. Secondary endpoints include interval changes in tricuspid annular geometry over one year, development of ≥ moderate TR, association between AF burden and tricuspid remodeling, identification of echocardiographic predictors of TR progression, and correlation between tricuspid and mitral valve changes.
Study results will be compared with two control groups: (1) subjects without AF and structurally normal hearts, and (2) patients with ≥ moderate atrial functional TR and AF, without significant left-sided valvular disease or prior valve interventions.
- Medical subject headings
- Atrial Fibrillation, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Participants with paroxysmal or persistent atrial fibrillation undergoing clinically indicated transthoracic echocardiography (TTE) prior to catheter ablation with acquisition of a three-dimensional (3D) tricuspid valve dataset. Participants will undergo repeat transthoracic echocardiography at 12-month follow-up and rhythm monitoring with Holter ECG according to standard clinical practice. No study-specific interventions are planned. | |
| Control group | The study cohort will be compared with control populations undergoing clinically indicated transthoracic echocardiography: 1. subjects with structurally normal hearts and no history of atrial fibrillation; 2. patients with atrial fibrillation and ≥ moderate atrial functional tricuspid regurgitation, in the absence of significant left-sided valvular disease or prior valvular surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation
Measured: 12 months
Secondary outcomes (5)
Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography
Measured: over 12 months
Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography
Measured: 12 months
Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)
Measured: 12 months
Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation
Measured: 12 months
Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start4 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas
- Responsible party
- Sponsor
- Investigators
- Gianluca Pontone, MD, Principal investigator, Centro Cardiologico Monzino, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617974
- Sponsor's protocol ID
- L2-592
- Acronym
- TRICUSPID-AF
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)
- ClinicalTrials.gov ID
- NCT07617974
- Acronym / sponsor ID
- TRICUSPID-AF / L2-592
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Jun 2026 (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 is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.
Detailed description
Patients with paroxysmal or persistent AF undergoing transthoracic echocardiography (TTE) prior to AF ablation will be enrolled and will undergo repeat TTE at 1-year follow-up. The echocardiographic assessment will include standard measurements, right atrial and right ventricular strain analysis, and 3D acquisitions of the tricuspid valve (and mitral valve, if feasible). Tricuspid valve geometry will be analyzed using an AI-powered 3D quantification tool. AF burden will be assessed through serial Holter ECG monitoring at baseline, 3, and 12 months.
The primary endpoint is the difference in 3D tricuspid annular geometry between patients with paroxysmal and persistent AF. Secondary endpoints include interval changes in tricuspid annular geometry over one year, development of ≥ moderate TR, association between AF burden and tricuspid remodeling, identification of echocardiographic predictors of TR progression, and correlation between tricuspid and mitral valve changes.
Study results will be compared with two control groups: (1) subjects without AF and structurally normal hearts, and (2) patients with ≥ moderate atrial functional TR and AF, without significant left-sided valvular disease or prior valve interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –Participants with paroxysmal or persistent atrial fibrillation undergoing clinically indicated transthoracic echocardiography (TTE) prior to catheter ablation with acquisition of a three-dimensional (3D) tricuspid valve dataset. Participants will undergo repeat transthoracic echocardiography at 12-month follow-up and rhythm monitoring with Holter ECG according to standard clinical practice. No study-specific interventions are planned. |
| Control group | – | –The study cohort will be compared with control populations undergoing clinically indicated transthoracic echocardiography: 1. subjects with structurally normal hearts and no history of atrial fibrillation; 2. patients with atrial fibrillation and ≥ moderate atrial functional tricuspid regurgitation, in the absence of significant left-sided valvular disease or prior valvular surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suitable for enrolment in the present study are those with paroxysmal or persistent atrial fibrillation (AF) undergoing transthoracic echocardiography (TTE) prior to AF ablation and will be study group. The study group will be compared with the following control groups: a) patients with structurally normal hearts and no history of AF; b) patients with ≥ moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.
Key inclusion criteria (4 listed)
- Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.
- all consecutive patients with structurally normal hearts and no history of AF or;
- moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.
Key exclusion criteria (5 listed)
- Moderate or greater TR assessed using a multiparametric approach;
- Arrhythmias other than AF;
- Prior AF ablations;
- Rapid ventricular response (average HR >110 bpm) during baseline TTE;
- Inadequate image quality
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
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation
Time frame: 12 months
5 secondary outcomes
Change From Baseline in 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography
Time frame: over 12 months
Number of Participants Developing ≥ Moderate Tricuspid Regurgitation Assessed by Echocardiography
Time frame: 12 months
Correlation Between Atrial Fibrillation Burden Assessed by Holter ECG and Change in 3D Tricuspid Annular Geometry (and Development of ≥ Moderate Tricuspid Regurgitation)
Time frame: 12 months
Association Between Baseline Echocardiographic Parameters and Development of ≥ Moderate Tricuspid Regurgitation
Time frame: 12 months
Correlation Between Changes in 3D Tricuspid and Mitral Annular Geometry Measured by 3D Echocardiography
Time frame: 12 months
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 Jun 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.
Gianluca Pontone, MD principal investigator
Centro Cardiologico Monzino, IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Tricuspid Regurgitation (TR), run by Centro Cardiologico Monzino at 1 site in Italy.
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 4 inclusion and 5 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 Jun 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 3D Tricuspid Annular Geometry Parameters Measured by 3D Echocardiography in Patients With Paroxysmal vs Persistent Atrial Fibrillation (time frame: 12 months). 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 Jun 2026.