CRM and Fusion Beats: Effects of Progressive Fusion on Intra-Left Ventricular Mechanical Function - Full Text View

Purpose

This study is looking at cardiac rhythm management and fusion beats in patients who have a pacemaker or implantable cardioverter-defibrillator, to determine if there is a correlation between the time between the contraction of the upper chambers of the heart (atrium) and the lower chambers of the heart, (ventricle)and heart function.

Some studies of people with pacemakers have been done to determine if shortening the time of contraction between the atrium and ventricle could benefit the function of the left ventricle. These studies have shown that there is no benefit in heart function.There have been other studies which have shown that chronic pacing of the right ventricle, especially with the lead placed at the tip of the right ventricle, can lead to a decrease in the function of the left ventricle and congestive heart failure. In some patients long term pacing of the right ventricle has also been associated with a reduction in the ability of the left ventricle to pump blood. This is know as a reduced left ventricular ejection fraction, which can be documented by an echocardiogram.

This study proposes to evaluate the acute effects of progressive paced fusion beats on the left ventricle to answer the question whether there is an delay between the atrium and ventricle that is "too long", or 'too short".

Condition

Cardiomyopathy

MedlinePlus related topics:

Cardiomyopathy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	CRM and Fusion Beats: Effects of Progressive Fusion on Intra-Left Ventricular Mechanical Function

Further study details as provided by St. Mary's Duluth Clinic Health System:

Primary Outcome Measures:

Acute effect of mechanical dyssynchrony measured by septal to lateral wall delay using tissue doppler imaging between baseline non-fused AV conduction and varying degrees of paced and native AV conduction. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stroke volume as measured by time velocity integral across the aorta valve between baseline non-fused AV conduction, and varying degrees of paced and native AV conduction. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

observation

30 patients with dualchamber pacemakers or ICDs

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pacemaker clinic or inpatient EP at St. Marys' Medical Center Duluth MN

Criteria

Inclusion Criteria:

Dual chamber pacemaker or ICD device LVEF 40% or less SR with intact AV conduction with a PR interval > 200 msec QRS < 120 msec Pacing RV lead in the RVA, system implanted within 6 weeks or chronically implanted system with histograms showing 20% or less RV pacing

Exclusion Criteria:

LVEF > 40%, any rhythm other than sinus rhythm Second degree or higher AV block Native HR < 40 bpm or > 90 bpm LV or CS lead in non-RVA location Chronically implanted system with > 20% RV pacing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610896

Contacts


Contact: Peggy Lipinski, RN	218-786-4566	mlipinski@smdc.org

Contact: Jill Lucca, CNP, MSN	218-786-4767	jlucca1@smdc.org

Locations


United States, Minnesota
	St. Mary's Duluth Clinic Health System	Recruiting
	Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

St. Mary's Duluth Clinic Health System

Investigators


Principal Investigator:	Michael E Mollerus, MD	St. Mary's Duluth Clinic Health System

More Information

Publications:

Auricchio A, Sommariva L, Salo RW, Scafuri A, Chiariello L. Improvement of cardiac function in patients with severe congestive heart failure and coronary artery disease by dual chamber pacing with shortened AV delay. Pacing Clin Electrophysiol. 1993 Oct;16(10):2034-43.

Gold MR, Feliciano Z, Gottlieb SS, Fisher ML. Dual-chamber pacing with a short atrioventricular delay in congestive heart failure: a randomized study. J Am Coll Cardiol. 1995 Oct;26(4):967-73.

Shinbane JS, Chu E, DeMarco T, Sobol Y, Fitzpatrick AP, Lau DM, Klinski C, Schiller NB, Griffin JC, Chatterjee K. Evaluation of acute dual-chamber pacing with a range of atrioventricular delays on cardiac performance in refractory heart failure. J Am Coll Cardiol. 1997 Nov 1;30(5):1295-300.

Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. Epub 2003 Jun 02.

Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65.

Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jais P, Haissaguerre M, Clementy J, Jimenez M. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation. 2004 Dec 21;110(25):3766-72. Epub 2004 Dec 6.

Tse HF, Lau CP. Long-term effect of right ventricular pacing on myocardial perfusion and function. J Am Coll Cardiol. 1997 Mar 15;29(4):744-9.

Lieberman R, Padeletti L, Schreuder J, Jackson K, Michelucci A, Colella A, Eastman W, Valsecchi S, Hettrick DA. Ventricular pacing lead location alters systemic hemodynamics and left ventricular function in patients with and without reduced ejection fraction. J Am Coll Cardiol. 2006 Oct 17;48(8):1634-41. Epub 2006 Sep 27.

Yu CM, Sanderson JE, Marwick TH, Oh JK. Tissue Doppler imaging a new prognosticator for cardiovascular diseases. J Am Coll Cardiol. 2007 May 15;49(19):1903-14. Epub 2007 Apr 30. Review.

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.

Tops LF, Schalij MJ, Holman ER, van Erven L, van der Wall EE, Bax JJ. Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation. J Am Coll Cardiol. 2006 Oct 17;48(8):1642-8. Epub 2006 Sep 27.

Catanzariti D, Maines M, Cemin C, Broso G, Marotta T, Vergara G. Permanent direct his bundle pacing does not induce ventricular dyssynchrony unlike conventional right ventricular apical pacing. An intrapatient acute comparison study. J Interv Card Electrophysiol. 2006 Aug;16(2):81-92. Epub 2006 Nov 18.

Victor F, Mabo P, Mansour H, Pavin D, Kabalu G, de Place C, Leclercq C, Daubert JC. A randomized comparison of permanent septal versus apical right ventricular pacing: short-term results. J Cardiovasc Electrophysiol. 2006 Mar;17(3):238-42.

Stambler BS, Ellenbogen K, Zhang X, Porter TR, Xie F, Malik R, Small R, Burke M, Kaplan A, Nair L, Belz M, Fuenzalida C, Gold M, Love C, Sharma A, Silverman R, Sogade F, Van Natta B, Wilkoff BL; ROVA Investigators. Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Nov;14(11):1180-6.

Olshansky B, Day JD, Moore S, Gering L, Rosenbaum M, McGuire M, Brown S, Lerew DR. Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study. Circulation. 2007 Jan 2;115(1):9-16. Epub 2006 Dec 18.

Olshansky B, Day J, McGuire M, Hahn S, Brown S, Lerew DR. Reduction of right ventricular pacing in patients with dual-chamber ICDs. Pacing Clin Electrophysiol. 2006 Mar;29(3):237-43.

Postaci N, Yeşil M, Susam I, Bayata S. The influence of different AV delays on left ventricular diastolic functions and on incidence of diastolic mitral regurgitation. Angiology. 1996 Sep;47(9):895-9.

Jutzy RV, Feenstra L, Pai R, Florio J, Bansal R, Aybar R, Levine PA. Comparison of intrinsic versus paced ventricular function. Pacing Clin Electrophysiol. 1992 Nov;15(11 Pt 2):1919-22.

Videen JS, Huang SK, Bazgan ID, Mechling E, Patton DD. Hemodynamic comparison of ventricular pacing, atrioventricular sequential pacing, and atrial synchronous ventricular pacing using radionuclide ventriculography. Am J Cardiol. 1986 Jun 1;57(15):1305-8.

Nielsen JC, Pedersen AK, Mortensen PT, Andersen HR. Programming a fixed long atrioventricular delay is not effective in preventing ventricular pacing in patients with sick sinus syndrome. Europace. 1999 Apr;1(2):113-20.

de Cock CC, Giudici MC, Twisk JW. Comparison of the haemodynamic effects of right ventricular outflow-tract pacing with right ventricular apex pacing: a quantitative review. Europace. 2003 Jul;5(3):275-8. Review.

Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.

Responsible Party:	St. Mary's Duluth Clinic Health System ( Michael E. Mollerus, MD )
Study ID Numbers:	12-07-02
First Received:	January 25, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00610896
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases

Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	St. Mary's Duluth Clinic Health System
Information provided by:	St. Mary's Duluth Clinic Health System
ClinicalTrials.gov Identifier:	NCT00610896