Percutaneous Ring Annuloplasty for Tricuspid Regurgitation
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cardiac Implants LLC
Must not be taking: Anticoagulants, Antiplatelets, Steroids, others
Disqualifiers: Heart failure, Valve stenosis, Renal impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a device called the CI annuloplasty ring, which helps a faulty heart valve close properly. It targets patients with moderate or worse tricuspid regurgitation. The ring is inserted through a vein in the neck and can be adjusted later to ensure it fits well and reduces the valve opening size.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have a contraindication to anticoagulant therapy and dual antiplatelet therapy, which might suggest some medication adjustments could be necessary. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment CI Percutaneous Ring Annuloplasty System for tricuspid regurgitation?
The first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring has been described for treating massive secondary tricuspid regurgitation, suggesting its potential effectiveness. Additionally, ring annuloplasty is considered the standard surgical technique for correcting tricuspid regurgitation, indicating that similar percutaneous approaches may also be effective.
12345Is the Percutaneous Ring Annuloplasty for Tricuspid Regurgitation safe?
The safety of percutaneous annuloplasty rings has been evaluated in animal studies, showing no adverse inflammatory response and good integration with surrounding tissue. However, there were complications in some cases, such as hemopericardium (bleeding into the heart's surrounding sac) leading to heart issues. Human studies are limited, but initial procedures have been performed without reported safety issues.
24678How is the CI Percutaneous Ring Annuloplasty System treatment different from other treatments for tricuspid regurgitation?
The CI Percutaneous Ring Annuloplasty System is unique because it offers a fully percutaneous (through the skin) approach to implanting a semirigid annuloplasty ring, which is traditionally done through open-heart surgery. This minimally invasive method aims to replicate the surgical gold standard of ring annuloplasty without the need for major surgery.
234910Eligibility Criteria
Adults over 18 with moderate to severe functional tricuspid regurgitation, a heart condition where the valve doesn't close tightly. They must have a left ventricular ejection fraction of at least 30%, suitable anatomy for the device, and be able to follow study procedures. Excluded are those with recent heart failure hospitalization, severe right ventricle issues, high lung artery pressure, or other conditions that could interfere with the trial.Inclusion Criteria
My heart condition limits my physical activity.
My heart valve issue is moderate to severe, as per specific guidelines.
A team of heart specialists agrees that a specific heart valve procedure is a good option for me.
+7 more
Exclusion Criteria
I have moderate to severe heart valve issues.
I have not had a stroke in the last 3 months.
Currently participating in another investigational drug or device study.
+28 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation
Transcatheter delivery and implantation of the Cardiac Implants annuloplasty ring
1 day
1 visit (in-person)
Adjustment
Manual adjustment of the ring approximately 90 days following implantation
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Multiple visits (in-person and virtual) at 30 days, 90 days, 180 days, 1 year, and annually up to 2 years post-adjustment
Participant Groups
The trial is testing a new Cardiac Implants Percutaneous Ring Annuloplasty System designed for people suffering from significant tricuspid valve leakage. It involves placing an annuloplasty ring via catheter and adjusting it after about three months to see if it improves heart function.
1Treatment groups
Experimental Treatment
Group I: CI Percutaneous Ring Annuloplasty SystemExperimental Treatment1 Intervention
Patients treated with the CI Percutaneous Ring Annuloplasty System
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell Medicine-New York Presbyterian HospitalNew York, NY
Hackensack University Medical CenterHackensack, NJ
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Who Is Running the Clinical Trial?
Cardiac Implants LLCLead Sponsor
References
Echocardiographic follow-up of tricuspid annuloplasty with a new three-dimensional ring in patients with functional tricuspid regurgitation. [2022]A new tricuspid valve (TV) annuloplasty system, the MC3 ring, includes a three-dimensional structure designed to remodel the TV annulus and preserve physiologic annular function.
First-in-Human Percutaneous Circumferential Annuloplasty for Secondary Tricuspid Regurgitation. [2021]Transcatheter therapies to treat tricuspid regurgitation are being developed, but few have attempted the gold standard of surgical repair: ring annuloplasty. We describe the first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation. (Level of Difficulty: Advanced.).
Medtronic Duran AnCore versus Edwards MC3 rings for tricuspid annuloplasty. [2018]Ring annuloplasty is now regarded as the standard surgical technique for the correction of tricuspid regurgitation (TR). However, comparative research on the durability of commercially available annuloplasty rings is limited. We reviewed early and late surgical results of tricuspid annuloplasty using the Duran AnCore and Edwards MC3 rings.
Percutaneous melody valve implantation in a native tricuspid valve following failed surgical repair. [2019]Transcatheter valve-in-valve and valve-in-ring implantation has become a common approach to treating patients with failed bioprosthetic tricuspid valves as well as failed surgical repairs of the tricuspid valve where an annuloplasty ring has been utilized. We describe a case where a Melody valve was percutaneously implanted in a native tricuspid valve with severe stenosis following surgical repair without a supporting annuloplasty ring.
Melody valve-in-ring procedure for mitral valve replacement: feasibility in four annuloplasty types. [2021]The recurrence of regurgitation after surgical mitral valve (MV) repair remains a significant clinical problem. Mitral annuloplasty rings are commonly used in MV repair procedures. The purpose of this study was to demonstrate the feasibility of transvenous valve-in-ring (VIR) implantation using the Melody valve (Medtronic, Minneapolis, MN), which is a valved-stent designed for percutaneous pulmonary valve replacement, and 4 distinct types of annuloplasty ring (AR) in an ovine model.
Biocompatibility and Systemic Safety of a Novel Implantable Annuloplasty Ring for the Treatment of Mitral Regurgitation in a Minipig Model. [2018]Prosthetic annuloplasty rings are a common treatment modality for mitral regurgitation, and recently, percutaneous implantation techniques have gained popularity due to their favorable safety profile. Although in common use, biocompatibility of annuloplasty rings has been reported only sparsely in the literature, and none of these reports used the percutaneous technique of implantation. We report on the biocompatibility and the systemic safety of a novel transcatheter mitral valve annuloplasty ring (AMEND™) in 6 minipigs. This device is composed of a nitinol tube surrounded by a braided polyethylene terephthalate fabric tube. The device produced no adverse inflammatory response, showing gradual integration between the metal ring and the fabric by normal host fibrocellular response, leading to complete neoendocardium coverage. There was no evidence for adverse reactions, rejection, or intolerance in the valvular structure. In 2 animals, hemopericardium resulted from the implantation procedure, leading to right-sided cardiac insufficiency with pulmonary edema and liver congestion. The findings reported herein can serve as a case study for the expected healing pathology reactions after implantation of transcatheter mitral valve annuloplasty rings.
Transcatheter self-expandable aortic valve implantation after undersized mitral annuloplasty. [2012]No data are available in the literature regarding the effectiveness and safety of transcatheter aortic valve implantation in patients who underwent previous mitral valve ring repair. Concerns exist related to the possible interference between the percutaneous aortic valve and the mitral annuloplasty ring. We report our experience with percutaneous aortic self-expandable valve implantation in a 76-year-old woman affected by severe aortic stenosis, previously operated on for "undersized" mitral annuloplasty repair of severe functional mitral regurgitation in dilated cardiomyopathy. No deformation of the nitinol tubing of the CoreValve device (CoreValve, Inc, Irvine, CA), neither distortion nor malfunction nor change of the conformation of the mitral ring occurred. No change in mitral function and regurgitation was evident at echocardiography monitoring, which was performed during the implant.
New Mitral Annuloplasty Ring Enables Oversizing of Transcatheter Heart Valve and Prevents Central or Paravalvular Leakage. [2017]Background Transcatheter valve-in-ring strategies have been developed to treat recurrent mitral regurgitation (MR) after failing surgical annuloplasty. However, suboptimal THV expansion with consecutive paravalvular leakage (PVL) is a procedure-immanent issue. Methods A rigid, saddle-shaped ring was cut at four locations. The segments were reconnected with pull-springs, rearranged to the original shape, and covered with a sewing cuff. The length of the annuloplasty ring construct, including extended pull-springs, was defined by the perimeter of an appropriate THV. We deployed a Sapien XT within the new ring, expanded it to its maximum extent, and investigated the geometrical changes. Results Fluoroscopy confirmed oval, saddle-shaped ring before dilation. After THV implantation, the ring segments spread apart and pull-springs were stretched. The extended ring changed its configuration from "oval" to "round" and anchored the THV leaving no paravalvular or central gaps as potential source for PVL. Conclusion We developed an expandable annuloplasty ring that is perfectly concerted to THV implantation. This proof-of-concept study revealed no PVL and good oversizing ability that might impact future annuloplasty ring design. Further studies have to evaluate durability and device safety.
Retrospective analysis of tricuspid valve repair using a novel surgical technique: A 7-year single-surgeon experience. [2021]Tricuspid annuloplasty is the optimal surgical repair technique for tricuspid regurgitation which improves mortality and morbidity. Ring annuloplasties is the techniques of choice. Here, we evaluate the efficacy and durability of a new method of interrupted pledgeted suture annuloplasty.
Placement of a rigid tricuspid annuloplasty ring over a flexible ring for the treatment of recurrent tricuspid regurgitation. [2016]We describe a technique that implants a rigid tricuspid annuloplasty ring over a previously inserted flexible ring for the treatment of recurrent tricuspid regurgitation. This technique avoids the trauma associated with the excision of a flexible ring in patients with friable annular tissue.