Clinical trial NCT04890821: Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
Official title: Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation Functional
Keywords: Tricuspid Valve
Annular Dilatation
Annuloplasty
Tricuspid Valve Repair
Lead sponsor: Cardiac Implants LLC
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: An early feasibility, multi-center, prospective, single-arm, non-randomized study to assess the safety and performance of the CI Percutaneous Ring Annuloplasty System in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR). Additional outcomes include short and long-term changes in echocardiographic, functional, and quality of life parameters post-adjustment.

The CI Ring Annuloplasty System is a percutaneous transcatheter repair device delivered by right heart catheterization through the right internal jugular vein. The System is designed to perform annuloplasty using a Ring Delivery System (RDS) to place a complete, flexible ring over the tricuspid annulus on the atrial side of the valve. Fluoroscopy and transesophageal echocardiography are used to guide and monitor the ring placement procedure.

After implantation, the ring becomes embedded within the fibrous tissue of the tricuspid annulus. Approximately 3 months following implantation, the ring is manually adjusted under echocardiographic and fluoroscopic imaging using an Adjustment Tool (AT) until desired reduction of the tricuspid annulus dimension is achieved. Following adjustment, the AT releases a fastener, securing the ring once optimal annular reduction is achieved.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Freedom from device or procedure-related mortality
timeFrame: 30 days post-adjustment
Secondary outcomes:
measure: Safety: Incidence of device or procedure-related major adverse events (MAE)
timeFrame: 30, 60, and 90 days post-implant; 30 days, 3 months, 6 months, 12 months, and 2-5 years (annually) post-adjustment
measure: Technical: Proportion of successful access, delivery, and retrieval device delivery system
timeFrame: 30 days post-implant and 30 days post-adjustment
measure: Technical: Proportion of successful deployment and positioning of the ring implant.
timeFrame: 30 days post-implant and 30 days post-adjustment
measure: Technical: Freedom from emergency surgery or reintervention
timeFrame: 30 days post-implant and 30 days post-adjustment
measure: Technical: Rate of Successful Implants
timeFrame: 30 days post-implant
measure: Technical: Proportion of Successful Procedures
timeFrame: 30 days post-implant and 30 days post-adjustment
measure: Technical: Number of device stakes embedded in tissue
timeFrame: 30 days post-implant, 30 days post-adjustment, and 1 year post-adjustment
measure: Mechanistic: Changes in TR Severity
timeFrame: 30 and 90 days post-implant; and 30, 90, 180, and 1-2 years (annually) post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes Tricuspid Valve (TV) Annular Diameter
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in TV Area
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Vena Contracta (VC) dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Proximal isovelocity surface area (PISA) effective regurgitant orifice area (EROA)
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Quantitive EROA
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in TV Regurgitant Volume
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Right Atrium (RA) Dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Right Ventricle (RV) Dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Inferior Vena Cava (IVC) Dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Left Atrium (LA) Dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Mechanistic: Echocardiographic changes: Changes in Left Ventricle (LV) Dimensions
timeFrame: 30 days, 90 days, 180 days, 1 year, and 2 years post-adjustment
measure: Functional: Changes in NYHA Classification
timeFrame: 1 year post-adjustment
measure: Functional: Changes in Distance Walked for Exercise Tolerance
timeFrame: 1 year post-adjustment
measure: Functional: Changes in Quality of Life Scores and Sub-Domains
timeFrame: 1 year post-adjustment
Other outcomes:
measure: Freedom from Heart Failure Events
timeFrame: 30 days, 90 days, 180 days, and 1-5 years (annually) post-adjustment
measure: Changes in Heart Failure Biomarkers
timeFrame: 180 days, 1 year, and 2 years post-adjustment
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medicine-New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Cardiac Implants LLC
name: Nodar Kipshidze, MPH
role: STUDY_DIRECTOR
References: