Heart Failure Clinical Trial
— QLVOfficial title:
Mapping of the Coronary Venous System in Patients With Heart Failure Presenting for CRT-D (Cardiac Resynchronization Therapy) Implantation. Correlating QLV Interval to Fluoroscopic LV (Left Ventricular) Lead Position.
NCT number | NCT02166762 |
Other study ID # | 121099 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | September 2015 |
Verified date | June 2019 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective clinical trial to determine the optimal QLV interval during implantation to achieve the best possible response from cardiac resynchronization therapy for heart failure patients.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are indicated for CRT-D devices according to the current guidelines for implantation of cardiac pacemakers and antiarrhythmia devices Exclusion Criteria: - Patients who are under the age of 18 - Patients who are pregnant - Patients who cannot have intravenous contrast due to allergic reactions or chronic renal insufficiency - Patients who are unable or unwilling for any reason to consent for this study |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Sulpizio Cardiovascular Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Boston Scientific Corporation |
United States,
Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. — View Citation
Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5. — View Citation
Ellenbogen KA, Gold MR, Meyer TE, Fernndez Lozano I, Mittal S, Waggoner AD, Lemke B, Singh JP, Spinale FG, Van Eyk JE, Whitehill J, Weiner S, Bedi M, Rapkin J, Stein KM. Primary results from the SmartDelay determined AV optimization: a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) trial: a randomized trial comparing empirical, echocardiography-guided, and algorithmic atrioventricular delay programming in cardiac resynchronization therapy. Circulation. 2010 Dec 21;122(25):2660-8. doi: 10.1161/CIRCULATIONAHA.110.992552. Epub 2010 Nov 15. — View Citation
Epstein AE, Dimarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO; American College of Cardiology/American Heart Association Task Force on Practice; American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: executive summary. Heart Rhythm. 2008 Jun;5(6):934-55. doi: 10.1016/j.hrthm.2008.04.015. Epub 2008 May 19. Review. Erratum in: Heart Rhythm. 2009 Jan;6(1):e1. — View Citation
Feldman AM, de Lissovoy G, Bristow MR, Saxon LA, De Marco T, Kass DA, Boehmer J, Singh S, Whellan DJ, Carson P, Boscoe A, Baker TM, Gunderman MR. Cost effectiveness of cardiac resynchronization therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial. J Am Coll Cardiol. 2005 Dec 20;46(12):2311-21. — View Citation
Gold MR, Niazi I, Giudici M, Leman RB, Sturdivant JL, Kim MH, Yu Y, Ding J, Waggoner AD. A prospective comparison of AV delay programming methods for hemodynamic optimization during cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2007 May;18(5):490-6. Epub 2007 Feb 21. — View Citation
Khan FZ: Targerted LV placement to guide cardiac resynchronization therapy. A randomized controlled trial (TARGET). ACC 2011, pp.
McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. Review. — View Citation
Singh JP, Fan D, Heist EK, Alabiad CR, Taub C, Reddy V, Mansour M, Picard MH, Ruskin JN, Mela T. Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy. Heart Rhythm. 2006 Nov;3(11):1285-92. Epub 2006 Aug 10. Erratum in: Heart Rhythm. 2006 Dec;3(12):1515. — View Citation
Singh JP, Klein HU, Huang DT, Reek S, Kuniss M, Quesada A, Barsheshet A, Cannom D, Goldenberg I, McNitt S, Daubert JP, Zareba W, Moss AJ. Left ventricular lead position and clinical outcome in the multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT) trial. Circulation. 2011 Mar 22;123(11):1159-66. doi: 10.1161/CIRCULATIONAHA.110.000646. Epub 2011 Mar 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QLV measurement | Measurements of the QLV interval is defined from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. | 15 minutes |
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