Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging

Heart Failure, Systolic Clinical Trial

Official title:

Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129635
• Other study ID #: IRB00036655
• Secondary ID: ACTSI-EP-001
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: January 17, 2015
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.

2. LV lead impedograms vary significantly depending on LV lead location.

3. There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with NYHA class III or IV heart failure

• LVEF = 30%

• QRS duration = 120 ms

Exclusion Criteria:

• Not a candidate for CRT implantation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Failure
• Heart Failure, Systolic
• Left Bundle Branch Block

Intervention

Procedure:
• Cardiac Resynchronization Therapy (CRT) implantation
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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. Epub 2007 Feb 19. — View Citation

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. Epub 2007 Apr 10. — 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

Couri DM, Mankad S. Cardiac resynchronization therapy. Curr Treat Options Cardiovasc Med. 2008 Dec;10(6):538-48. — View Citation

Fornwalt BK, Arita T, Bhasin M, Voulgaris G, Merlino JD, León 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. Epub 2007 Jul 23. — View Citation

Fornwalt BK, Gonzales PC, Delfino JG, Eisner R, León 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. — View Citation

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. — View Citation

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. — View Citation

Koos R, Neizel M, Schummers G, Krombach GA, Stanzel S, Günther RW, Kelm M, Kühl 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;10:49. doi: 10.1186/1532-429X-10-49. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Osswald S, Cron T, Grädel C, Hilti P, Lippert M, Ströbel 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. — View Citation

RUSHMER RF, CRYSTAL DK, WAGNER C, ELLIS RM. Intracardiac impedance plethysmography. Am J Physiol. 1953 Jul;174(1):171-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No