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Cardiac Dimensions, Inc. Publications

Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial.
Tomasz Siminiak, Justina C. Wu, Michael Haude, Uta C. Hoppe, Jerzy Sadowski, Janusz Lipiecki, Jean Fajadet, Amil M. Shah, Ted Feldman, David M. Kaye, Steven L. Goldberg, Wayne C. Levy, Scott D. Solomon, David G. Reuter
European Journal of Heart Failure : May 21, 2012
Results of the TITAN trial evaluating the CARILLON® Mitral Contour System® in treating functional mitral regurgitation in symptomatic heart failure patients.

Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy.
Hoppe UC, Brandt MC, Degen H, Dodos F, Schneider T, Stoepel C, Kroener A, Haude M. [PMID: 19472350]
Catheter Cardiovasc Interv 2009 Apr 27.
Study documenting ability to insert CRT lead through previously deployed CARILLON device.

Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.
Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt M, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. [PMID: 19597051]
Circulation. 2009; 120: 326-333.
First clinical trial evaluating the CARILLON® Mitral Contour System® used to treat functional mitral regurgitation in symptomatic heart failure patients.

Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial).
Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. [PMID: 19660613]
Am J Cardiol. 2009 Aug 15;104(4):565-70.
Procedural results from the AMADEUS trial using the CARILLON® Mitral Contour System®.

Acute and chronic reduction of functional mitral regurgitation in experimental heart failure by percutaneous mitral annuloplasty.
Maniu CV, Patel JB. Reuter DG. et al. [PMID: 15489099]
J Am Coll Cardiol 2004; 44: 1652-61
Pre-clinical study demonstrating acute and chronic efficacy of CARILLON therapy in an animal heart failure model.



Associated Publications

Cardiac resynchronization in chronic heart failure.
Abraham WT, Fisher WG, Smith AL, et al. [PMID: 12063368]
N Engl J Med 2002; 346: 1845-53.
Study describing the clinical benefit of implanting a cardiac resynchronization device in patients with heart failure and electrical dyssynchrony. Magnitude of exercise benefit in both intervention and blinded control group described.

Mitral valve surgery in heart failure: insights from the Acorn Clinical Trial.
Acker MA, Bolling S, Shemin R, Kirklin J, Oh JK, Mann DL, Fessup M, Sabbah HN, Starling RC, Kubo S. [PMID: 16935112]
J Thorac and Cardiovasc Surg 2006; 132(3): 568-577.
Surgical study evaluating the control arm from the ACORN Trial demonstrating the safety and efficacy of ring annuloplasty primarily in non-ischemic patients with heart failure and mitral regurgitation (80% of which was functional).

Mitral regurgitation in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both: prognostic significance and relation to ventricular size and function.
Amigoni M, Meris A, Thune JJ, et al. [PMID: 17251259]
European Heart J 2007; 28: 326-333.
Substudy of post-MI patients with FMR showing an increase in death or hospitalization for heart failure per unit increase in MR jet / LA area ratio. (Adjusted hazard ratio: 1.04 (1.02 – 1.07))

2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. [PMID: 18820172]
Circulation. 2008 Oct 7; 118(15): e523-661
Practice guidelines describing the standard of care for patients with heart failure and functional mitral regurgitation

Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.
Green PC, Porter CB, Bresnahan DR, Spertus JA. [PMID: 10758967]
JACC 2000; 35(5):1245-55.
Description of validity, sensitivity and reliability of the Kansas City Cardiomyopathy Questionnaire to assess heart failure patients.

2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults. A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation.
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW; American College of Cardiology Foundation; American Heart Association. [PMID: 19358937]
J Am Coll Cardiol. 2009 Apr 14;53(15):e1-e90.
Practice guidelines developed by the heart failure society regarding the management of chronic heart failure.

Dynamic mitral regurgitation. An important determinant of the hemodynamic response to load alterations and inotropic therapy in severe heart failure.
Keren G, Katz S, Strom J, et al. [PMID: 2502326]
Circulation 1989 Aug; 80(2): 306-13.
Effect of exercise on functional mitral regurgitation characterized. Study showed that with exercise, mitral regurgitation volume increased greater than 70%, while forward stroke volume substantially decreased.

Mitral regurgitation in patients with advanced systolic heart failure.
Patel JB, Borgeson DD, Barnes ME, et al. [PMID: 15309693]
J. Cardiac Failure 2004; 10(4): 285-291.
Epidemiologic study evaluating prevalence of functional mitral regurgitation in patients with advanced heart failure.

The role of ischemic mitral regurgitation in the pathogenesis of acute pulmonary edema.
Pierard LA, Lancellotti P. [PMID: 15483281]
N Engl J Med 2004; 351: 1627-34.
Study evaluating the effect of exercise induced changes in functional mitral regurgitation

Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure.
Trichon BH, Felker GM, Shaw LK, et al. [PMID: 12615256]
JACC 2002 March 6; 39(5)(Suppl A): 1205-155 – 194A.
Study of 2057 patients with ejection fraction < 40% showing that compared to those without MR, those with mild and mod/severe MR had an 18% and 53% increased risk of death respectively.

CAUTION: The CARILLON® Mitral Contour System® is CE-Marked and approved for sale in the European Union and elsewhere in the world.
In the United States, the CARILLON Mitral Contour System is an investigational device and limited by Federal law to investigational use.

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