Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers

NCT06914570 | Recruiting DMC

• 1 other identifier: 09C407
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation.
2. 2.to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level.
3. 3.to determine the clinical impact of new or worsening TR after CIED implantation.
4. 4.to explore the treatment strategies for lead-related TR (observational).

Conditions

Cardiac Pacing, Artificial; Tricuspid Valve Regurgitation, Non-rheumatic

Keywords

Cardiac Implantable Electrical Devices; Tricuspid regurgitation; Three-dimensional echocardiography; Right ventricular remodeling

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (4)

• Incidence of mortality (all-cause, cardiovascular, non-cardiovascular)

  5 years

• Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics

  1 year, and annually through 5 years

• New York Heart Association (NYHA) functional class

  at 1 day, 3 months, 1 year, and annually through 5 years

• Incidence of tricuspid valve intervention (either transcatheter or surgical)

  1 year, and annually through 5 years

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing new implantation of a CIED

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

San Luca Hospital

Milan, MI, 20149, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 32589674 BACKGROUND

• Kanawati 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.

  PMID: 33132050 BACKGROUND

• Papageorgiou 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.

  PMID: 32470533 BACKGROUND

• Delling 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.

  PMID: 26833208 BACKGROUND

• Al-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.

  PMID: 25377489 BACKGROUND

• Hoke 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.

  PMID: 24449717 BACKGROUND

• Baquero 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.

  PMID: 24022757 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Luigi Badano, MD, Ph.D.

  Istituto Auxologico Italiano, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi P Badano, MD, Ph.D.

CONTACT

+3902619112319; l.badano@auxologico.it

Michele Tomaselli, MD, Ph.D.

CONTACT

02619112648; m.tomaselli5@campus.unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 6, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 24, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: Researchers who are members of Institutions who will subscribe a data transfer agreement for this specific study

Locations

IT (1)