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A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation (RESHAPE-HF)

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ClinicalTrials.gov Identifier: NCT01772108
Recruitment Status : Terminated (As recruitment rate was lower than anticipated)
First Posted : January 21, 2013
Last Update Posted : January 8, 2015
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Evalve

Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
  Recruitment Status : Terminated
  Actual Primary Completion Date : December 2014
  Estimated Study Completion Date : January 2015

Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 November 10, 2015
December 14, 2015
Publications:
Zannad F. Acute heart failure syndromes: the 'Cinderella' of heart failure research. European Journal Supplements. 2005 April 7;(suppl B):B8-B127.
Reducing Heart Failure Hospitalization. Genesis Heart Institute. http://www.genesishealth.com/ghi/news/hf_hospitalization 2011 Oct 18.
American Heart Association/American College of Cardiology (AHA/ACC) 2009 update HF guidelines.
Southard J, and Rogers J. Current Catheter-Based Treatments of Functional Mitral Regurgitation. Cardiac Interventions. 2007 June.
Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.
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. 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. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007.
A Class IIb; Level of Evidence C recommendation is defined as: "Recommendation's usefulness/efficacy less well established. Only diverging expert opinion, case studies, or standard of care."
Optimal medical and/or device therapy includes optimal stabilization of symptoms with the use of appropriate evidence-based therapies including medicines, revascularization, and cardiac resynchronization therapy with or without cardioverter-defibrillator as indicated, per the European Society of Cardiology (ESC) guidelines
Nishimura RA, Schaff HV: Mitral regurgitation: timing of surgery. In: Otto CM, Bonow RO, ed. Valvular Heart Disease: A Companion to Braunwald's Heart Disease, Philadelphia: Saunders/Elsevier; 2009:274-290.
The Six Minute Walk Test will be administered according to the ATS Statement: Guidelines for the Six-Minute Walk Test, Official Statement of the American Thoracic Society, Approved march 2002. Am J Crit Care Med 2002; 166:111-117)
The Society of Thoracic Surgeons (2005-2012). Online STS Risk Calculator: http://riskcalc.sts.org/STSWebRiskCalc273/
Nishimura RA, Carabello BA, Faxon DP, Freed MD, Lytle BW, O'Gara PT, O'Rourke RA, Shah PM, 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, Smith SC Jr, Jacobs AK, Buller CE, Creager MA, Ettinger SM, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Page RL, Tarkington LG, Yancy CW Jr; American College of Cardiology/American Heart Association Task Force. ACC/AHA 2008 guideline update on valvular heart disease: focused update on infective endocarditis: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Aug 19;118(8):887-96. doi: 10.1161/CIRCULATIONAHA.108.190377. Epub 2008 Jul 28.
National Institute for Health and Clinical Excellence (NICE) Methods for Technology Appraisal. London. 2008. http://www.nice.org.uk/media/4A6/0F/SelectedFurtherReading210708.pdf
EuroSCORE Calculator: http://www.euroscore.org/calc.html
http://www.euroscore.org/calcold.html
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.