Localization of CRT According to Echocardiography: LOCATE-Pilot Study

NCT00234611 | Unknown

• 1 other identifier: MH-MDT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the majority of heart failure patients who qualify for and receive a cardiac resynchronization therapy (CRT) device feel better than before their implant. However, there are some patients who do not improve after the implant. Michigan Heart is sponsoring a research study called LOCATE-Pilot to help understand whether the information from an echocardiogram, performed before implanting the CRT device, improves patients' responses to CRT. This is being done by evaluating your heart's function with an echocardiogram, to measure your heart's response during therapy. The study hypothesis is that response to CRT may be optimized by guiding left ventricular lead placement to the maximally delayed, viable basal segment of the left ventricle.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Efficacy: Indexed end systolic volume decrease>15% by biplane Simpson's technique at 6 month follow-up.

• Safety: CRT implantation morbidity; mortality

Secondary Outcomes (5)

• Clinical composite (6 month clinical assessment in HF clinic): 6 minute hall walk distance, MLWHF QOL score, NYHA functional classification

• Clinical outcome at study termination (6 month follow-up for last patient enrolled): vital status (all cause mortality), cardiac mortality, unplanned hospitalization for major cardiovascular event

• Proportion of diagnostic pulsed wave Doppler baseline studies

• Success rate at Echo guided implantation (implantation of LV lead to target segment)

• Outcomes stratified by concordance (pacing most delayed, viable segment)

Interventions

Echocardiogram guided left ventricular lead placement PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male/female patients
• NYHA class III and IV chronic heart failure
• symptoms refractory to standard therapy (beta blocker and either ACE-I or ARB on stable dosages for 1 month minimum and duration of 3 months therapy minimum)
• patient has signed and dated informed consent
• patient able to receive pectoral device implant
• QRS\>= 130 ms
• EF \<= 35%
• follow-up at Michigan Heart CHF clinic feasible
• patient understanding of protocol and willing to comply

You may not qualify if:

• recent myocardial infarction (\<3 months)
• recent surgical or percutaneous revascularization (\<3months)
• age \< 18 months
• permanent AF without AV junction ablation
• life expectancy under 6 months
• women of child-bearing potential and not willing or able to take birth control
• mechanical tricuspid valve
• prior orthotopic heart transplantation
• intermittent inotropic therapy or inotropic-dependent

Sponsors & Collaborators

• Michigan Heart, PC: lead
• Medtronic: collaborator

Study Sites (1)

Michigan Heart, PC

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (6)

• McAlister FA, Ezekowitz JA, Wiebe N, Rowe B, Spooner C, Crumley E, Hartling L, Klassen T, Abraham W. Systematic review: cardiac resynchronization in patients with symptomatic heart failure. Ann Intern Med. 2004 Sep 7;141(5):381-90. doi: 10.7326/0003-4819-141-5-200409070-00101. Epub 2004 Aug 16.

  PMID: 15353430 BACKGROUND

• Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.

  PMID: 15753115 BACKGROUND

• Pitzalis MV, Iacoviello M, Romito R, Massari F, Rizzon B, Luzzi G, Guida P, Andriani A, Mastropasqua F, Rizzon P. Cardiac resynchronization therapy tailored by echocardiographic evaluation of ventricular asynchrony. J Am Coll Cardiol. 2002 Nov 6;40(9):1615-22. doi: 10.1016/s0735-1097(02)02337-9.

  PMID: 12427414 BACKGROUND

• Bax JJ, Bleeker GB, Marwick TH, Molhoek SG, Boersma E, Steendijk P, van der Wall EE, Schalij MJ. Left ventricular dyssynchrony predicts response and prognosis after cardiac resynchronization therapy. J Am Coll Cardiol. 2004 Nov 2;44(9):1834-40. doi: 10.1016/j.jacc.2004.08.016.

  PMID: 15519016 BACKGROUND

• Yu CM, Fung WH, Lin H, Zhang Q, Sanderson JE, Lau CP. Predictors of left ventricular reverse remodeling after cardiac resynchronization therapy for heart failure secondary to idiopathic dilated or ischemic cardiomyopathy. Am J Cardiol. 2003 Mar 15;91(6):684-8. doi: 10.1016/s0002-9149(02)03404-5.

  PMID: 12633798 BACKGROUND

• Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.

  PMID: 12063368 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven E Girard, MD, PhD

  Michigan Heart, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: September 1, 2005
• Study Completion: April 1, 2007
• Last Updated: November 6, 2006

Record last verified: 2006-11

Locations

US (1)