RECRUITING

Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

Conditions

Tricuspid Regurgitation Functional Tricuspid Valve Annular Dilatation Annuloplasty Tricuspid Valve Repair

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).

Official Title

Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation

Quick Facts

Study Start:2021-12

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04890821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines. 2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure. 3. Age ≥ 18 years old at the time of enrollment. 4. New York Heart Associate Classification ≥ II. 5. Symptoms of right heart failure despite optimized medical therapy. 6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment. 7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure 8. The subject has suitable anatomy for investigational device implantation as per imaging requirements. 9. The subject has read and signed the informed consent prior to study related procedures. 10. The subject is willing and able to comply with all required follow-up evaluations and assessments.	1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment. 2. Severe RV dysfunction as assessed by echocardiography. 3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.). 4. Currently participating in another investigational drug or device study. 5. Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE). 6. Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure. 7. Tricuspid valve stenosis. 8. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate. 9. Intra-cardiac thrombus, mass or vegetation requiring active treatment. 10. Prior tricuspid repair or tricuspid replacement. 11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated. 12. History of cardiac transplantation. 13. Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE). 14. Endocarditis or severe infection within 12 months of scheduled implant procedure. 15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure. 16. Cerebro-Vascular Accident within the previous 3 months. 17. Hemodynamic instability or on IV inotropes. 18. Contraindication to anticoagulant therapy and dual antiplatelet therapy. 19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure. 20. Severe renal impairment or on dialysis. 21. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \< 1 year), or lead to difficulties for subject compliance with study requirements. 22. Acute anemia. 23. Chronic Oral Steroid Use ≥ 6 months. 24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure. 25. Pulmonary embolism within the last 6 months. 26. Tricuspid Valve Tethering distance \> 10 mm. 27. Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography. 28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure. 29. Contra-indicated for blood transfusion or refuses transfusion. 30. Patient undergoing emergency treatment. 31. Patient without appropriate jugular access.

Inclusion Criteria

Exclusion Criteria

1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
2. Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.
3. Age ≥ 18 years old at the time of enrollment.
4. New York Heart Associate Classification ≥ II.
5. Symptoms of right heart failure despite optimized medical therapy.
6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment.
7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
8. The subject has suitable anatomy for investigational device implantation as per imaging requirements.
9. The subject has read and signed the informed consent prior to study related procedures.
10. The subject is willing and able to comply with all required follow-up evaluations and assessments.

1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
2. Severe RV dysfunction as assessed by echocardiography.
3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
4. Currently participating in another investigational drug or device study.
5. Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE).
6. Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure.
7. Tricuspid valve stenosis.
8. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
9. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
10. Prior tricuspid repair or tricuspid replacement.
11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
12. History of cardiac transplantation.
13. Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
14. Endocarditis or severe infection within 12 months of scheduled implant procedure.
15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
16. Cerebro-Vascular Accident within the previous 3 months.
17. Hemodynamic instability or on IV inotropes.
18. Contraindication to anticoagulant therapy and dual antiplatelet therapy.
19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
20. Severe renal impairment or on dialysis.
21. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \< 1 year), or lead to difficulties for subject compliance with study requirements.
22. Acute anemia.
23. Chronic Oral Steroid Use ≥ 6 months.
24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
25. Pulmonary embolism within the last 6 months.
26. Tricuspid Valve Tethering distance \> 10 mm.
27. Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
29. Contra-indicated for blood transfusion or refuses transfusion.
30. Patient undergoing emergency treatment.
31. Patient without appropriate jugular access.

Contacts and Locations

Study Contact

Nodar Kipshidze, MPH

CONTACT

1-917-370-6247

Nodar@cardiac-implants.com

Principal Investigator

Nodar Kipshidze, MPH

STUDY_DIRECTOR

Cardiac Implants LLC

Study Locations (Sites)

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Cardiac Implants LLC

Nodar Kipshidze, MPH, STUDY_DIRECTOR, Cardiac Implants LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12

Study Completion Date2027-09

Study Record Updates

Study Start Date2021-12

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Tricuspid Valve
Annular Dilatation
Annuloplasty
Tricuspid Valve Repair

Additional Relevant MeSH Terms

Tricuspid Regurgitation Functional