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| ID | Type | Description | Link |
|---|---|---|---|
| ACTSI-EP-001 | Other Identifier | Other |
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Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.
This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT Candidate | Experimental | Patients with NYHA Class III or IV heart failure; EF ≤ 30% and QRS duration ≥ 120 ms, who are scheduled for CRT surgery. Intervention: Cardiac Resynchronization Therapy (CRT) implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy (CRT) implantation | Procedure | The impedance measurement is performed during device implantation following CMR. After the RV and LV leads are inserted, secured and tested, they will be connected to the impedance monitor. Impedance recording of at least ten beats will be acquired and stored for future analysis. Each recording will be tagged with the anatomical location of the LV lead. Subsequently, the LV lead will be moved to a different location and the same procedure will be repeated until accessible coronary sinus sites are exhausted. The ultimate LV lead location is determined by the implanting electrophysiologist and is not constrained by the study protocol. Finally, the LV lead will be tested again and the rest of the implantation procedure will proceed as routine. Arm: CRT Candidate |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map. | Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve | Acute intraoperative measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map. | Ts: The average time from the sensed RV IEGM to the peak of the LV impedance curve. Tp: The average time from the paced RV IEGM to the peak of the LV impedance curve. Td: The difference between Ts and Tp (Tp - Ts). | Acute intraoperative measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S. Lloyd, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 19723700 |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D002037 | Bundle-Branch Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003692 | Delayed-Action Preparations |
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|
| Background |
| Jessup M. MADIT-CRT--breathtaking or time to catch our breath? N Engl J Med. 2009 Oct 1;361(14):1394-6. doi: 10.1056/NEJMe0907335. Epub 2009 Sep 1. No abstract available. |
| 19723701 | Background | Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1. |
| 19026184 | Background | Couri DM, Mankad S. Cardiac resynchronization therapy. Curr Treat Options Cardiovasc Med. 2008 Dec;10(6):538-48. doi: 10.1007/s11936-008-0046-5. |
| 17764446 | Background | Lloyd MS, Heeke S, Lerakis S, Langberg JJ. Reverse polarity pacing: the hemodynamic benefit of anodal currents at lead tips for cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2007 Nov;18(11):1167-71. doi: 10.1111/j.1540-8167.2007.00943.x. |
| 19175447 | Background | Mounsey JP, Knisley SB. Anodal capture, cathodal capture, and left ventricular cardiac excitation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):650-2. doi: 10.1111/j.1540-8167.2008.01418.x. Epub 2009 Jan 9. No abstract available. |
| 19207760 | Background | Theis C, Bavikati VV, Langberg JJ, Lloyd MS. The relationship of bipolar left ventricular pacing stimulus intensity to cardiac depolarization and repolarization in humans with cardiac resynchronization devices. J Cardiovasc Electrophysiol. 2009 Jun;20(6):645-9. doi: 10.1111/j.1540-8167.2008.01378.x. Epub 2009 Dec 15. |
| 17309913 | Background | Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19. |
| 17426079 | Background | Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10. |
| 18458170 | Background | 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. |
| 18983646 | Background | Koos R, Neizel M, Schummers G, Krombach GA, Stanzel S, Gunther RW, Kelm M, Kuhl HP. Feasibility and initial experience of assessment of mechanical dyssynchrony using cardiovascular magnetic resonance and semi-automatic border detection. J Cardiovasc Magn Reson. 2008 Nov 4;10(1):49. doi: 10.1186/1532-429X-10-49. |
| 15906282 | Background | Tsao J, Kozerke S, Boesiger P, Pruessmann KP. Optimizing spatiotemporal sampling for k-t BLAST and k-t SENSE: application to high-resolution real-time cardiac steady-state free precession. Magn Reson Med. 2005 Jun;53(6):1372-82. doi: 10.1002/mrm.20483. |
| 13065515 | Background | RUSHMER RF, CRYSTAL DK, WAGNER C, ELLIS RM. Intracardiac impedance plethysmography. Am J Physiol. 1953 Jul;174(1):171-4. doi: 10.1152/ajplegacy.1953.174.1.171. No abstract available. |
| 3957369 | Background | Salo RW, Wallner TG, Pederson BD. Measurement of ventricular volume by intracardiac impedance: theoretical and empirical approaches. IEEE Trans Biomed Eng. 1986 Feb;33(2):189-95. doi: 10.1109/TBME.1986.325890. No abstract available. |
| 17272334 | Background | Kaye G, Edgar D, Mudawi T, Lippert M, Czygan G. Can transventricular intracardiac impedance measurement discriminate haemodynamically unstable ventricular arrhythmias in human? Europace. 2007 Feb;9(2):122-6. doi: 10.1093/europace/eul150. |
| 11060870 | Background | Osswald S, Cron T, Gradel C, Hilti P, Lippert M, Strobel J, Schaldach M, Buser P, Pfisterer M. Closed-loop stimulation using intracardiac impedance as a sensor principle: correlation of right ventricular dP/dtmax and intracardiac impedance during dobutamine stress test. Pacing Clin Electrophysiol. 2000 Oct;23(10 Pt 1):1502-8. doi: 10.1046/j.1460-9592.2000.01502.x. |
| 18666147 | Background | Fornwalt BK, Gonzales PC, Delfino JG, Eisner R, Leon AR, Oshinski JN. Quantification of left ventricular internal flow from cardiac magnetic resonance images in patients with dyssynchronous heart failure. J Magn Reson Imaging. 2008 Aug;28(2):375-81. doi: 10.1002/jmri.21446. |
| 17643956 | Background | Fornwalt BK, Arita T, Bhasin M, Voulgaris G, Merlino JD, Leon AR, Fyfe DA, Oshinski JN. Cross-correlation quantification of dyssynchrony: a new method for quantifying the synchrony of contraction and relaxation in the heart. J Am Soc Echocardiogr. 2007 Dec;20(12):1330-1337.e1. doi: 10.1016/j.echo.2007.04.030. Epub 2007 Jul 23. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |