ArrhythmiaPhase 3NCT00000561
Mode Selection Trial in Sinus Node Dysfunction (MOST)
A Phase 3 study testing pacemaker, artificial in people with Arrhythmia and Cardiovascular Diseases, run by Mt. Sinai Medical Center, Miami.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arrhythmia, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- pacemaker, artificial
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1995to May 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women with sick sinus syndrome.
About this study
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.
Read the detailed description
BACKGROUND:
Permanent pacing is estimated to cost one billion dollars annually in health care costs in the United States. Initially, pacing was primarily confined to ventricular pacing with limited sensing, programming and pacing capacity. Tremendous growth has occurred in pacing technology, making available dual chamber pacing with sophisticated sensing, pacing, and rate control. These more advanced pacemakers are more costly and complicated to place surgically.
One of the most common indications for pacing is sick sinus syndrome. Initial therapy is usually medical to inhibit the tachyarrhythmias (most commonly paroxysmal atrial fibrillation). However, if symptomatic bradycardia results, then permanent pacing is commonly employed. The appropriate type of pacing in this setting is not clearly defined and is controversial.
The development of atrioventricular pacing was principally aimed at improving cardiac hemodynamics and creating a more physiological heart rate control. Hemodynamic studies have clearly shown the benefit of this approach in many patients, particularly those with decreased left ventricular compliance in whom atrial activity contributes significantly to cardiac output. Lack of synchronization between the upper and lower chambers of the heart caused by pacing the ventricle alone can result in a constellation of symptoms commonly referred to as "pacemaker syndrome".
The underlying mechanisms by which dual chamber pacing is purported to improve outcome is straightforward; in patients with normal sinus rhythm, cardiac output is improved by 15 to 30 percent. In addition, a number of retrospective studies that have compared single chamber with atrial-based or dual chamber pacing have suggested that the latter may prevent adverse clinical events such as atrial fibrillation, congestive heart failure, cerebral vascular accidents, and death. While none of these studies was a randomized trial, the literature is consistent with a concept that dual mode pacing results in improved hemodynamics and a more favorable outcome in patients with sick sinus syndrome. However, the data do not provide definitive answers because of small sample sizes and methodological problems. A major problems with all previous studies is probable selection bias favoring implantation of dual chamber devices in younger, healthier patients.
Several small studies have compared functional status and other quality of life measures between single and dual chamber pacing modes and have suggested better quality of life outcomes for the dual chamber mode. Again, these conclusions are severly hampered by the sample sizes, the lack of random assignment or adequate statistical adjustment to control for confounding, use of outdated and/or invalid measures, and potential response bias due to awareness of mode assignment.
DESIGN NARRATIVE:
A multicenter, randomized clinical trial. All patients received a dual chamber pacemaker capable of either single or dual chamber rate modulated pacing. Patients were then randomized to either the single chamber mode or the dual chamber mode. Patients with prior stroke were pre-stratified. Clinical and electrocardiographic data were collected during a 1.5 to 4.5 year follow-up. The primary endpoint was either: first occurrence of stroke, or; total (all-cause) mortality. Secondary endpoints included health status, cost-effectiveness, cardiovascular mortality, composite of any of the three major adverse effects expected in sick sinus syndrome patients (total mortality alone or first stroke or congestive heart failure hospitalization), first occurrence of atrial fibrillation, heart failure score, pacemaker syndrome, health status in women and in the elderly, and outcome of patients with risk factors for pacemaker syndrome. Enrollment was completed in October, 1999 with a total of 2,010 patients.
Quality of life and economic issues were assessed in patients at entry and annually for three years. Questionnaire-based measures of health status and quality of life were compared in the two pacing groups for the entire population and subgroups defined by age and gender. The economic substudy measured the comparative costs, both direct and indirect medical and nonmedical, of the two pacing modes in an attempt to determine the most cost-effective approach to pacemaker treatment of sick sinus syndrome.
Recruitment started October 1, 1995 and was completed October 4, 1999 with 2,010 patients enrolled.
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Diseases, Sick Sinus Syndrome, Vascular Diseases, Cerebrovascular Accident
- Being tested
- pacemaker, artificial
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases, Sick Sinus Syndrome, Vascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemaker, artificialDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1995
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Gervasio Lamas, Icahn School of Medicine at Mount SinaiKerry Lee, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000561
- Sponsor's protocol ID
- 105
- Other IDs
- U01HL049804
- Status last verified
- May 2005
- First submitted
- 27 Oct 1999
- Last updated
- 23 Feb 2016
- Results posted
- No
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. doi: 10.1067/mhj.2000.109652.
PubMed 11011325Lamas 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. doi: 10.1056/NEJMoa013040.
PubMed 12063369Glotzer 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. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.
PubMed 12668495Sweeney 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. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
PubMed 12782566Flaker 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. doi: 10.1016/S0002-8703(03)00429-0.
PubMed 14597940Greenspon 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. doi: 10.1016/j.jacc.2003.09.067.
PubMed 15120821Link 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. doi: 10.1016/j.jacc.2003.10.072.
PubMed 15172414Sweeney 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. doi: 10.1046/j.1540-8167.2004.03146.x.
PubMed 15028043Rinfret 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. doi: 10.1161/01.CIR.0000151810.69732.41. Epub 2005 Jan 3.
PubMed 15630030Shukla 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. doi: 10.1016/j.hrthm.2004.12.012.
PubMed 15851312Sweeney 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. doi: 10.1161/01.CIR.0000165061.23825.A2. Epub 2005 May 2.
PubMed 15867173
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mode Selection Trial in Sinus Node Dysfunction (MOST)
- ClinicalTrials.gov ID
- NCT00000561
- Acronym / sponsor ID
- 105
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Diseases, Sick Sinus Syndrome, Vascular Diseases, Cerebrovascular Accident
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 1995
- Study completion
- May 2002
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Permanent pacing is estimated to cost one billion dollars annually in health care costs in the United States. Initially, pacing was primarily confined to ventricular pacing with limited sensing, programming and pacing capacity. Tremendous growth has occurred in pacing technology, making available dual chamber pacing with sophisticated sensing, pacing, and rate control. These more advanced pacemakers are more costly and complicated to place surgically.
One of the most common indications for pacing is sick sinus syndrome. Initial therapy is usually medical to inhibit the tachyarrhythmias (most commonly paroxysmal atrial fibrillation). However, if symptomatic bradycardia results, then permanent pacing is commonly employed. The appropriate type of pacing in this setting is not clearly defined and is controversial.
The development of atrioventricular pacing was principally aimed at improving cardiac hemodynamics and creating a more physiological heart rate control. Hemodynamic studies have clearly shown the benefit of this approach in many patients, particularly those with decreased left ventricular compliance in whom atrial activity contributes significantly to cardiac output. Lack of synchronization between the upper and lower chambers of the heart caused by pacing the ventricle alone can result in a constellation of symptoms commonly referred to as "pacemaker syndrome".
The underlying mechanisms by which dual chamber pacing is purported to improve outcome is straightforward; in patients with normal sinus rhythm, cardiac output is improved by 15 to 30 percent. In addition, a number of retrospective studies that have compared single chamber with atrial-based or dual chamber pacing have suggested that the latter may prevent adverse clinical events such as atrial fibrillation, congestive heart failure, cerebral vascular accidents, and death. While none of these studies was a randomized trial, the literature is consistent with a concept that dual mode pacing results in improved hemodynamics and a more favorable outcome in patients with sick sinus syndrome. However, the data do not provide definitive answers because of small sample sizes and methodological problems. A major problems with all previous studies is probable selection bias favoring implantation of dual chamber devices in younger, healthier patients.
Several small studies have compared functional status and other quality of life measures between single and dual chamber pacing modes and have suggested better quality of life outcomes for the dual chamber mode. Again, these conclusions are severly hampered by the sample sizes, the lack of random assignment or adequate statistical adjustment to control for confounding, use of outdated and/or invalid measures, and potential response bias due to awareness of mode assignment.
DESIGN NARRATIVE:
A multicenter, randomized clinical trial. All patients received a dual chamber pacemaker capable of either single or dual chamber rate modulated pacing. Patients were then randomized to either the single chamber mode or the dual chamber mode. Patients with prior stroke were pre-stratified. Clinical and electrocardiographic data were collected during a 1.5 to 4.5 year follow-up. The primary endpoint was either: first occurrence of stroke, or; total (all-cause) mortality. Secondary endpoints included health status, cost-effectiveness, cardiovascular mortality, composite of any of the three major adverse effects expected in sick sinus syndrome patients (total mortality alone or first stroke or congestive heart failure hospitalization), first occurrence of atrial fibrillation, heart failure score, pacemaker syndrome, health status in women and in the elderly, and outcome of patients with risk factors for pacemaker syndrome. Enrollment was completed in October, 1999 with a total of 2,010 patients.
Quality of life and economic issues were assessed in patients at entry and annually for three years. Questionnaire-based measures of health status and quality of life were compared in the two pacing groups for the entire population and subgroups defined by age and gender. The economic substudy measured the comparative costs, both direct and indirect medical and nonmedical, of the two pacing modes in an attempt to determine the most cost-effective approach to pacemaker treatment of sick sinus syndrome.
Recruitment started October 1, 1995 and was completed October 4, 1999 with 2,010 patients enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pacemaker, artificial | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 11011325Lamas 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. doi: 10.1067/mhj.2000.109652.
- Background: PubMed 12063369Lamas 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. doi: 10.1056/NEJMoa013040.
- Background: PubMed 12668495Glotzer 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. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.
- Background: PubMed 12782566Sweeney 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. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
- Background: PubMed 14597940Flaker 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. doi: 10.1016/S0002-8703(03)00429-0.
- Background: PubMed 15120821Greenspon 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. doi: 10.1016/j.jacc.2003.09.067.
- Background: PubMed 15172414Link 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. doi: 10.1016/j.jacc.2003.10.072.
- Background: PubMed 15028043Sweeney 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. doi: 10.1046/j.1540-8167.2004.03146.x.
- Background: PubMed 15630030Rinfret 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. doi: 10.1161/01.CIR.0000151810.69732.41. Epub 2005 Jan 3.
- Background: PubMed 15851312Shukla 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. doi: 10.1016/j.hrthm.2004.12.012.
- Background: PubMed 15867173Sweeney 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. doi: 10.1161/01.CIR.0000165061.23825.A2. Epub 2005 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gervasio Lamas
Icahn School of Medicine at Mount Sinai
Kerry Lee
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pacemaker, artificial in people with Arrhythmia and Cardiovascular Diseases, run by Mt. Sinai Medical Center, Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000561, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.