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

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Mode Selection Trial in Sinus Node Dysfunction (MOST)

This study has been completed.

First Received on October 27, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000561

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 III

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Diseases Pacemakers and Implantable Defibrillators Vascular Diseases

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women with sick sinus syndrome.

Contacts and Locations

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

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:	Gervasio Lamas	Mount Sinai School of Medicine
Investigator:	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. 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 02.

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 03.

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
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Sick Sinus Syndrome
Cerebral Infarction
Stroke
Vascular Diseases
Pathologic Processes

Arrhythmia, Sinus
Heart Block
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012