Cardiac Pacing, ArtificialCIED-REMTRICNCT06914570
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
An observational study of Cardiac Pacing, Artificial and Tricuspid Valve Regurgitation, Non-rheumatic, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 24 Feb 2029
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing new implantation of a CIED
Who may be able to join
- Age ≥ 18 years
- Patient able and willing to give informed consent in written form before the index procedure
- Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
- Patients undergoing any new CIED implantation with or without transvalvular lead
- Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers
Who cannot join
- Previous or present CIED
- Life expectancy < 12 months due to non-cardiac condition
- Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
- Previous tricuspid valve intervention (transcatheter, surgical)
- Participation in another study, which would lead to deviations from this trial protocol
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
San Luca Hospital
Milan, MI, 20149
LUIGI BADANO, MD, 02619112319, lpbadano@gmail.com
Michele Tomaselli, MD. Ph.D., +39 02619112648, m.tomaselli5@campus.unimib.it
About this study
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging.
The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation.
Read more
Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years.
They can be summarized as follows:
- to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation.
- to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level.
- to determine the clinical impact of new or worsening TR after CIED implantation.
- to explore the treatment strategies for lead-related TR (observational).
- Keywords
- Cardiac Implantable Electrical Devices, Tricuspid regurgitation, Three-dimensional echocardiography, Right ventricular remodeling
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CIED | Patients undergoing new implantation of a CIED Inclusion criteria * Age ≥ 18 years * Patient is able and willing to give informed consent in written form before the index procedure * Patient understands the purpose, the potential risks and the benefits of the study and is willing to participate in all parts of the follow-up * Patients undergoing any new CIED implantation with or without transvalvular lead * Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers Exclusion criteria * Previous or present CIED * Life expectancy < 12 months due to non-cardiac condition * Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months * Previous tricuspid valve intervention (transcatheter, surgical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TR at least one grade after new CIED implantation
TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.
Measured: 5 years
Secondary outcomes (4)
Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)
Measured: 5 years
Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics
Measured: 1 year, and annually through 5 years
New York Heart Association (NYHA) functional class
Measured: at 1 day, 3 months, 1 year, and annually through 5 years
Incidence of tricuspid valve intervention (either transcatheter or surgical)
Measured: 1 year, and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion24 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac Pacing, ArtificialStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Badano, MD, Ph.D., Principal investigator, Istituto Auxologico Italiano, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914570
- Sponsor's protocol ID
- 09C407
- Acronym
- CIED-REMTRIC
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depends on subscription of a Data transfer agreement
Publications
Seo J, Kim DY, Cho I, Hong GR, Ha JW, Shim CY. Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation. PLoS One. 2020 Jun 26;15(6):e0235230. doi: 10.1371/journal.pone.0235230. eCollection 2020.
PubMed 32589674Kanawati J, Ng ACC, Khan H, Yu C, Hyun K, Abed H, Kritharides L, Sy RW. Long-Term Follow-Up of Mortality and Heart Failure Hospitalisation in Patients With Intracardiac Device-Related Tricuspid Regurgitation. Heart Lung Circ. 2021 May;30(5):692-697. doi: 10.1016/j.hlc.2020.08.028. Epub 2020 Oct 31.
PubMed 33132050Papageorgiou N, Falconer D, Wyeth N, Lloyd G, Pellerin D, Speechly-Dick E, Segal OR, Lowe M, Rowland E, Lambiase PD, Chow AW, Bhattacharyya S. Effect of tricuspid regurgitation and right ventricular dysfunction on long-term mortality in patients undergoing cardiac devices implantation: >10-year follow-up study. Int J Cardiol. 2020 Nov 15;319:52-56. doi: 10.1016/j.ijcard.2020.05.062. Epub 2020 May 27.
PubMed 32470533Delling FN, Hassan ZK, Piatkowski G, Tsao CW, Rajabali A, Markson LJ, Zimetbaum PJ, Manning WJ, Chang JD, Mukamal KJ. Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads. Am J Cardiol. 2016 Mar 15;117(6):988-92. doi: 10.1016/j.amjcard.2015.12.038. Epub 2016 Jan 6.
PubMed 26833208Al-Bawardy R, Krishnaswamy A, Rajeswaran J, Bhargava M, Wazni O, Wilkoff B, Tuzcu EM, Martin D, Thomas J, Blackstone E, Kapadia S. Tricuspid regurgitation and implantable devices. Pacing Clin Electrophysiol. 2015 Feb;38(2):259-66. doi: 10.1111/pace.12530. Epub 2014 Nov 7.
PubMed 25377489Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21.
PubMed 24449717Baquero GA, Yadav P, Skibba JB, Banchs JE, Linton-Frazier LN, Lengerich EJ, Samii SM, Penny-Peterson E, Wolbrette DL, Luck JC, Naccarelli GV, Gonzalez MD. Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads. J Interv Card Electrophysiol. 2013 Dec;38(3):197-202. doi: 10.1007/s10840-013-9826-2.
PubMed 24022757
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
- ClinicalTrials.gov ID
- NCT06914570
- Acronym / sponsor ID
- CIED-REMTRIC / 09C407
- Keywords
- Cardiac Implantable Electrical Devices, Tricuspid regurgitation, Three-dimensional echocardiography, Right ventricular remodeling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 24 Feb 2029 (estimated)
- First posted
- 6 Apr 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 single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging.
The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation.
Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years.
They can be summarized as follows:
- to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation.
- to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level.
- to determine the clinical impact of new or worsening TR after CIED implantation.
- to explore the treatment strategies for lead-related TR (observational).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIED | – | –Patients undergoing new implantation of a CIED Inclusion criteria * Age ≥ 18 years * Patient is able and willing to give informed consent in written form before the index procedure * Patient understands the purpose, the potential risks and the benefits of the study and is willing to participate in all parts of the follow-up * Patients undergoing any new CIED implantation with or without transvalvular lead * Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers Exclusion criteria * Previous or present CIED * Life expectancy < 12 months due to non-cardiac condition * Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months * Previous tricuspid valve intervention (transcatheter, surgical) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing new implantation of a CIED
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient able and willing to give informed consent in written form before the index procedure
- Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
- Patients undergoing any new CIED implantation with or without transvalvular lead
- Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers
Key exclusion criteria (5 listed)
- Previous or present CIED
- Life expectancy < 12 months due to non-cardiac condition
- Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
- Previous tricuspid valve intervention (transcatheter, surgical)
- Participation in another study, which would lead to deviations from this trial protocol
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
Change in TR at least one grade after new CIED implantation
Time frame: 5 years
TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.
4 secondary outcomes
Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)
Time frame: 5 years
Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics
Time frame: 1 year, and annually through 5 years
New York Heart Association (NYHA) functional class
Time frame: at 1 day, 3 months, 1 year, and annually through 5 years
Incidence of tricuspid valve intervention (either transcatheter or surgical)
Time frame: 1 year, and annually through 5 years
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 6 Apr 2025.
- Background: PubMed 32589674Seo J, Kim DY, Cho I, Hong GR, Ha JW, Shim CY. Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation. PLoS One. 2020 Jun 26;15(6):e0235230. doi: 10.1371/journal.pone.0235230. eCollection 2020.
- Background: PubMed 33132050Kanawati J, Ng ACC, Khan H, Yu C, Hyun K, Abed H, Kritharides L, Sy RW. Long-Term Follow-Up of Mortality and Heart Failure Hospitalisation in Patients With Intracardiac Device-Related Tricuspid Regurgitation. Heart Lung Circ. 2021 May;30(5):692-697. doi: 10.1016/j.hlc.2020.08.028. Epub 2020 Oct 31.
- Background: PubMed 32470533Papageorgiou N, Falconer D, Wyeth N, Lloyd G, Pellerin D, Speechly-Dick E, Segal OR, Lowe M, Rowland E, Lambiase PD, Chow AW, Bhattacharyya S. Effect of tricuspid regurgitation and right ventricular dysfunction on long-term mortality in patients undergoing cardiac devices implantation: >10-year follow-up study. Int J Cardiol. 2020 Nov 15;319:52-56. doi: 10.1016/j.ijcard.2020.05.062. Epub 2020 May 27.
- Background: PubMed 26833208Delling FN, Hassan ZK, Piatkowski G, Tsao CW, Rajabali A, Markson LJ, Zimetbaum PJ, Manning WJ, Chang JD, Mukamal KJ. Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads. Am J Cardiol. 2016 Mar 15;117(6):988-92. doi: 10.1016/j.amjcard.2015.12.038. Epub 2016 Jan 6.
- Background: PubMed 25377489Al-Bawardy R, Krishnaswamy A, Rajeswaran J, Bhargava M, Wazni O, Wilkoff B, Tuzcu EM, Martin D, Thomas J, Blackstone E, Kapadia S. Tricuspid regurgitation and implantable devices. Pacing Clin Electrophysiol. 2015 Feb;38(2):259-66. doi: 10.1111/pace.12530. Epub 2014 Nov 7.
- Background: PubMed 24449717Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21.
- Background: PubMed 24022757Baquero GA, Yadav P, Skibba JB, Banchs JE, Linton-Frazier LN, Lengerich EJ, Samii SM, Penny-Peterson E, Wolbrette DL, Luck JC, Naccarelli GV, Gonzalez MD. Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads. J Interv Card Electrophysiol. 2013 Dec;38(3):197-202. doi: 10.1007/s10840-013-9826-2.
- Individual participant dataSharing planned: Yes. Depends on subscription of a Data transfer agreement
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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.
Luigi Badano, MD, Ph.D. principal investigator
Istituto Auxologico Italiano, 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 Cardiac Pacing, Artificial and Tricuspid Valve Regurgitation, Non-rheumatic, run by Istituto Auxologico Italiano 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 5 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 6 Apr 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 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?
Contact Luigi P Badano, MD, Ph.D. (+3902619112319, l.badano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TR at least one grade after new CIED implantation (time frame: 5 years). 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 NCT06914570, which also lists 7 linked publications.
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 6 Apr 2025.