Mode Selection Trial in Sinus Node Dysfunction (MOST) - Full Text View

Purpose

To determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of adverse clinical events such as stroke, quality of life and function, and cost effectiveness.

Condition	Intervention	Phase
Arrhythmia Cardiovascular Diseases Heart Diseases Sick Sinus Syndrome Vascular Diseases Cerebrovascular Accident	Device: pacemaker, artificial	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: progressive familial heart block sick sinus syndrome

U.S. FDA Resources

Further study details as provided by Mt. Sinai Medical Center, Miami:


Study Start Date:	June 1995
Estimated Study Completion Date:	May 2002

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women with sick sinus syndrome.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000561

Sponsors and Collaborators

Mt. Sinai Medical Center, Miami

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


OverallOfficial:	Gervasio Lamas	Icahn School of Medicine at Mount Sinai
OverallOfficial:	Kerry Lee	Duke University

More Information

Publications:

Lamas GA, Lee K, Sweeney M, Leon A, Yee R, Ellenbogen K, Greer S, Wilber D, Silverman R, Marinchak R, Bernstein R, Mittleman RS, Lieberman EH, Sullivan C, Zorn L, Flaker G, Schron E, Orav EJ, Goldman L. The mode selection trial (MOST) in sinus node dysfunction: design, rationale, and baseline characteristics of the first 1000 patients. Am Heart J. 2000 Oct;140(4):541-51.

Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62.

Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. Epub 2003 Mar 24.

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 2.

Flaker G, Greenspon A, Tardiff B, Schron E, Goldman L, Hellkamp A, Lee K, Lamas G; Mode Selection Trial (MOST) Investigators. Death in patients with permanent pacemakers for sick sinus syndrome. Am Heart J. 2003 Nov;146(5):887-93.

Greenspon AJ, Hart RG, Dawson D, Hellkamp AS, Silver M, Flaker GC, Schron E, Goldman L, Lee KL, Lamas GA; MOST Study Investigators. Predictors of stroke in patients paced for sick sinus syndrome. J Am Coll Cardiol. 2004 May 5;43(9):1617-22.

Link MS, Hellkamp AS, Estes NA 3rd, Orav EJ, Ellenbogen KA, Ibrahim B, Greenspon A, Rizo-Patron C, Goldman L, Lee KL, Lamas GA; MOST Study Investigators. High incidence of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based pacing in the Mode Selection Trial (MOST). J Am Coll Cardiol. 2004 Jun 2;43(11):2066-71.

Sweeney MO, Hellkamp AS, Ellenbogen KA, Glotzer TV, Silverman R, Yee R, Lee KL, Lamas GA; MOST Investigators. Prospective randomized study of mode switching in a clinical trial of pacemaker therapy for sinus node dysfunction. J Cardiovasc Electrophysiol. 2004 Feb;15(2):153-60.

Rinfret S, Cohen DJ, Lamas GA, Fleischmann KE, Weinstein MC, Orav J, Schron E, Lee KL, Goldman L. Cost-effectiveness of dual-chamber pacing compared with ventricular pacing for sinus node dysfunction. Circulation. 2005 Jan 18;111(2):165-72. Epub 2005 Jan 3.

Shukla HH, Hellkamp AS, James EA, Flaker GC, Lee KL, Sweeney MO, Lamas GA; Mode Selection Trial (MOST) Investigators. Heart failure hospitalization is more common in pacemaker patients with sinus node dysfunction and a prolonged paced QRS duration. Heart Rhythm. 2005 Mar;2(3):245-51.

Sweeney MO, Hellkamp AS, Lee KL, Lamas GA; Mode Selection Trial (MOST) Investigators. Association of prolonged QRS duration with death in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2005 May 17;111(19):2418-23. Epub 2005 May 2.


ClinicalTrials.gov Identifier:	NCT00000561 History of Changes
Other Study ID Numbers:	105 U01HL049804
Study First Received:	October 27, 1999
Last Updated:	February 22, 2016
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Sick Sinus Syndrome Cardiovascular Diseases Heart Diseases Vascular Diseases Stroke Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Arrhythmia, Sinus Arrhythmias, Cardiac Heart Block Pathologic Processes

ClinicalTrials.gov processed this record on September 28, 2016