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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT implantation | Other | Standard CRT indication. Assessment of acute response to CRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac resynchronization therapy device implantation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| dP\dt max response to different ventricular lead pacing sites | To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lead movements and electrical measures | Compare metrics derived from 2/3-D reconstructions of lead movement to electrical measures (e.g. Q-LV-timing or VCG) at different pacing configurations in patients undergoing a CRT-implant. | 6 months |
| Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Rikshospitalet | Oslo | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15152059 | Background | Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423. | |
| 15753115 |
| Label | URL |
|---|---|
| Center for Cardiological Innovation | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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To compare metrics derived from 2/3-D reconstructions of lead movement to Force-Interval-Relation at different pacing configurations in patients undergoing a CRT-implant. |
| 6 months |
| Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map | To compare metrics derived from 2/3-D reconstructions of lead movement to CardioGuide Motion Map at different pacing configurations in patients undergoing a CRT-implant. | 6 months |
| 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. |
| 12063368 | 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. |
| 20421518 | Background | Fornwalt BK, Sprague WW, BeDell P, Suever JD, Gerritse B, Merlino JD, Fyfe DA, Leon AR, Oshinski JN. Agreement is poor among current criteria used to define response to cardiac resynchronization therapy. Circulation. 2010 May 11;121(18):1985-91. doi: 10.1161/CIRCULATIONAHA.109.910778. Epub 2010 Apr 26. |
| 11748094 | Background | 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. doi: 10.1161/hc5001.102229. |
| 15485432 | Background | Rossillo A, Verma A, Saad EB, Corrado A, Gasparini G, Marrouche NF, Golshayan AR, McCurdy R, Bhargava M, Khaykin Y, Burkhardt JD, Martin DO, Wilkoff BL, Saliba WI, Schweikert RA, Raviele A, Natale A. Impact of coronary sinus lead position on biventricular pacing: mortality and echocardiographic evaluation during long-term follow-up. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1120-5. doi: 10.1046/j.1540-8167.2004.04089.x. |
| 20298819 | Background | Merchant FM, Heist EK, McCarty D, Kumar P, Das S, Blendea D, Ellinor PT, Mela T, Picard MH, Ruskin JN, Singh JP. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm. 2010 May;7(5):639-44. doi: 10.1016/j.hrthm.2010.01.035. Epub 2010 Feb 1. |
| 19215835 | Background | Mullens W, Verga T, Grimm RA, Starling RC, Wilkoff BL, Tang WHW. Persistent hemodynamic benefits of cardiac resynchronization therapy with disease progression in advanced heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):600-607. doi: 10.1016/j.jacc.2008.08.079. |
| 21184174 | Background | Blendea D, Singh JP. Lead positioning strategies to enhance response to cardiac resynchronization therapy. Heart Fail Rev. 2011 May;16(3):291-303. doi: 10.1007/s10741-010-9212-4. |
| 21884950 | Background | Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042. |
| 21791536 | Background | Bogaard MD, Houthuizen P, Bracke FA, Doevendans PA, Prinzen FW, Meine M, van Gelder BM. Baseline left ventricular dP/dtmax rather than the acute improvement in dP/dtmax predicts clinical outcome in patients with cardiac resynchronization therapy. Eur J Heart Fail. 2011 Oct;13(10):1126-32. doi: 10.1093/eurjhf/hfr094. Epub 2011 Jul 26. |
| 15851221 | Background | Butter C, Stellbrink C, Belalcazar A, Villalta D, Schlegl M, Sinha A, Cuesta F, Reister C. Cardiac resynchronization therapy optimization by finger plethysmography. Heart Rhythm. 2004 Nov;1(5):568-75. doi: 10.1016/j.hrthm.2004.07.002. |
| 16635996 | Background | Whinnett ZI, Davies JE, Willson K, Chow AW, Foale RA, Davies DW, Hughes AD, Francis DP, Mayet J. Determination of optimal atrioventricular delay for cardiac resynchronization therapy using acute non-invasive blood pressure. Europace. 2006 May;8(5):358-66. doi: 10.1093/europace/eul017. |
| 16709698 | Background | Whinnett ZI, Davies JE, Willson K, Manisty CH, Chow AW, Foale RA, Davies DW, Hughes AD, Mayet J, Francis DP. Haemodynamic effects of changes in atrioventricular and interventricular delay in cardiac resynchronisation therapy show a consistent pattern: analysis of shape, magnitude and relative importance of atrioventricular and interventricular delay. Heart. 2006 Nov;92(11):1628-34. doi: 10.1136/hrt.2005.080721. Epub 2006 May 18. |
| 20667892 | Background | Bocchiardo M, Meyer zu Vilsendorf D, Militello C, Lippert M, Czygan G, Schauerte P, Gaita F, Stellbrink C. Resynchronization therapy optimization by intracardiac impedance. Europace. 2010 Nov;12(11):1589-95. doi: 10.1093/europace/euq273. Epub 2010 Jul 28. |
| 20176716 | Background | Turcott RG, Witteles RM, Wang PJ, Vagelos RH, Fowler MB, Ashley EA. Measurement precision in the optimization of cardiac resynchronization therapy. Circ Heart Fail. 2010 May;3(3):395-404. doi: 10.1161/CIRCHEARTFAILURE.109.900076. Epub 2010 Feb 22. |
| 16500302 | Background | Jia P, Ramanathan C, Ghanem RN, Ryu K, Varma N, Rudy Y. Electrocardiographic imaging of cardiac resynchronization therapy in heart failure: observation of variable electrophysiologic responses. Heart Rhythm. 2006 Mar;3(3):296-310. doi: 10.1016/j.hrthm.2005.11.025. |
| 22126664 | Background | Shetty AK, Duckett SG, Ma YL, Kapetanakis S, Ginks M, Bostock J, Carr-White G, Rhode K, Razavi R, Rinaldi CA. The acute hemodynamic response to LV pacing within individual branches of the coronary sinus using a quadripolar lead. Pacing Clin Electrophysiol. 2012 Feb;35(2):196-203. doi: 10.1111/j.1540-8159.2011.03268.x. Epub 2011 Nov 29. |
| 17552884 | Background | Tysler M, Kneppo P, Turzova M, Svehlikova J, Karas S, Heblakova E, Hana K, Filipova S. Noninvasive assessment of local myocardium repolarization changes using high resolution surface ECG mapping. Physiol Res. 2007;56 Suppl 1:S133-S141. doi: 10.33549/physiolres.931312. Epub 2007 May 31. |
| 19843927 | Background | van Deursen C, van Geldorp IE, Rademakers LM, van Hunnik A, Kuiper M, Klersy C, Auricchio A, Prinzen FW. Left ventricular endocardial pacing improves resynchronization therapy in canine left bundle-branch hearts. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):580-7. doi: 10.1161/CIRCEP.108.846022. Epub 2009 Aug 10. |
| Oslo University Hospital | View source |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |