SUMMIT Trial

This page is intended to provide clinical trial information only. The products and procedures discussed on this page are currently in clinical study and are not approved for commercial use. CAUTION: Tendyne is an investigational device. Limited by Federal (U.S.) law to investigational use only.

SUMMIT Trial Examines TRANSCATHETER MITRAL VALVE IMPLANTATION (TMVI) with Tendyne Mitral Valve

The SUMMIT Trial (Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation) is now underway, and will be enrolling patients at up to 80 sites in the U.S., Canada, Europe, and Japan.1

The trial is examining a treatment with the Tendyne Mitral Valve System, for patients who have symptomatic, moderate-to-severe or severe mitral regurgitation (MR) or mitral annular calcification (MAC) and who are appropriate candidates for TMVI. The objective of this trial is to:

  • Determine whether this technology improves clinical outcomes for the large number of patients suffering from the debilitating symptoms of moderate-to-severe or severe MR
  • Compare the TMVI outcomes to MitraClip transcatheter mitral valve repair, the standard of care for patients not suitable for mitral valve surgery

For more information, visit www.clinicaltrials.gov.

Tendyne Transcatheter Mitral Valve Implantation

The Tendyne Mitral Valve is a bioprosthesis designed to reduce MR and improve blood flow through the heart. The following steps provide a general overview of the Tendyne procedure.

The Tendyne valve is a uniquely-designed device consisting of:

  • A dual frame valve contoured to fit the natural shape of the native anatomy
  • A tether connected to an apical pad that is placed over the apical access site and supports valve securement

1. Access to the heart is gained through a small incision in the chest between the ribs.

 


2. The Tendyne valve is placed in the heart through a catheter.


 


3. The tether is secured to a pad at the bottom of the heart. The valve, tether, and pad are designed to become a permanant implant, reduce MR, and improve blood flow.

Tendyne animation video

The Tendyne valve is a uniquely designed device consisting of:

  • A dual frame valve contoured to fit the natural shape of the native anatomy
  • A tether connecting to an integrated apical pad that supports valve securement and is placed over the apical access site

Eligibility Criteria

  • Symptomatic, moderate-to-severe or severe MR of any etiology (primary, secondary, or mixed) or severe MAC
  • NYHA Class ≥ II (if Class IV, patients must be ambulatory)
  • Determination by the site’s heart team that the subject has been adequately treated for coronary artery disease (eg, revascularization), left ventricular (LV) dysfunction (eg, cardiac resynchronization therapy), and heart failure (eg, guideline-directed medical therapy)

Randomized cohort eligibility limited to:

  • Patients suitable for TMVI with Tendyne and indicated for transcatheter mitral valve repair with MitraClip

Non-randomized cohort eligibility limited to:

  • Subjects who are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair

MAC cohort eligibility limited to:

  • Patients who have severe MAC resulting in symptomatic mitral valve disease (MR ≥ Grade III, or severe mitral stenosis [MS], or both moderate MR and moderate MS) rendering the subject unsuitable for mitral valve surgery

SUMMIT Trial Design

This is a prospective, controlled, multi-center clinical investigation. Investigators anticipate a 48-month recruitment period, with subject follow-up continuing for an additional 60 months.
 

This is a prospective, controlled, multi-center clinical investigation. Investigators anticipate a 48-month recruitment period, with subject follow-up continuing for an additional 60 months.

*2017 ASE Guidelines.
†Associated with MR ≥ Grade III, severe MS, or moderate MR with moderate MS.

STUDY Endpoints

MVARC = Mitral Valve Academic Research Consortium.

MVARC = Mitral Valve Academic Research Consortium.

About Mitral Regurgitation

A progressive disease, MR initiates a cascade of events progressing to heart failure, then death, if left untreated.4 The 1-year mortality of MR can be as high as 57%.5

Certain medical therapies, such as beta-blockers and renin-angiotensin-aldosterone pathway inhibitors, have been associated with reverse LV remodeling.6 In some cases, they have been associated with diminished MR severity.7 However, data indicate that adherence to cardiology society guidelines is poor, and many patients go without recommended treatment.8-10 In addition, the outlook for patients whose severe MR persists in spite of optimal medical therapy remains poor.11

Despite meeting the indications for surgical intervention, nearly 50% of MR patients are not candidates for surgery due to comorbidities or advanced age.12 A minimally invasive treatment option that offers an acceptable benefit-risk profile for these patients is needed.

MAT-1900796 v1.0 | Item approved for OUS use only.

References
  1. SUMMIT Trial (Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation). Clinical Investigation Plan No. CS0004-P.
  2. Muller DWM, et al. Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation: a global feasibility trial. J Am Coll Cardiol. 2017;69(4):381-391.
  3. Sorajja P, et al. Initial feasibility study of a new transcatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019;73(11):1250-1260.
  4. Lim DS, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192. doi: 10.1016/j.jacc.2013.10.021.
  5. Cioffi G, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117. doi: 10.1016/j.ejheart.2005.01.016.
  6. Cokkinos DV, et al. Left ventricular remodeling: a problem in search of solutions. Eur Cardiol Rev. 2016;11(1):29–35.
  7. Seneviratne B, et al. Effect of captopril on functional mitral regurgitation in dilated heart failure: a randomised double blind placebo controlled trial. Br Heart J. 1994;72(1):63-68.
  8. Bach DS, et al. Failure of guideline adherence for intervention in patients with severe mitral regurgitation. J Am Coll Cardiol. 2009;54(9):860-865.
  9. Badhwar V, et al. Longitudinal outcome of isolated mitral repair in older patients: results from 14,604 procedures performed from 1991 to 2007. Ann Thorac Surg. 2012;94(6):1870-1877.
  10. Toledano K, et al. Mitral regurgitation: determinants of referral for cardiac surgery by Canadian cardiologists. Can J Cardiol. 2007;23(3):209-214.
  11. Nasser R, et al. Evolution of functional mitral regurgitation and prognosis in medically managed heart failure patients with reduced ejection fraction. JACC Heart Fail. 2017;5:652-659.
  12. Mirabel M, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.

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