Primary Prevention of Sudden Cardiac ArrestMADIT-RITNCT00947310
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
A study testing Standard ICD programming, High rate cutoff and Long delay in people with Primary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Prevention of Sudden Cardiac Arrest
- What is being tested?
- Standard ICD programming, High rate cutoff and Long delay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
- Patient in sinus rhythm
- Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
- Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent
Who cannot join
- Patient with an implanted pacemaker or CRT-P
- Patient with existing ICD or CRT-D device components
- Patient with a history of VT or VF
- Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
- Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
- Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
Show all 19Show fewer
- Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- Patient with second or third degree heart block
- Patient in NYHA Class IV
- Patient who is pregnant or plans to become pregnant during the course of the trial
- Patient with irreversible brain damage from preexisting cerebral disease
- Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
- Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl
- Patient participating in any other clinical trial
- Patient unwilling or unable to cooperate with the protocol
- Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
- Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
- Patient unwilling to sign the consent for participation
- Patient whose physician does not allow participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester (Multiple Facilities Participating World Wide)
Rochester, New York, 14642
About this study
Official title: IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
Read the detailed description
The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.
- Being tested
- Standard ICD programming, High rate cutoff, Long delay
- Keywords
- Inappropriate therapy, ICD therapy, Primary prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ICD programmingDevice
Standard ICD programming
High rate cutoffDevice
Programming of a high rate cutoff
Long delayDevice
Programming of a prolonged delay
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Standard ICD Programming Receives: Device: Standard ICD programming |
| B | Experimental | High rate cutoff Receives: Device: High rate cutoff |
| C | Experimental | Long ICD duration delay Receives: Device: Long delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate ICD Therapy
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Measured: Average of 1.4 years follow-up
Secondary outcomes (2)
All-cause Mortality
Measured: Average 1.4 years of follow-up
Syncope
First episode of syncope
Measured: Average of 1.4 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary Prevention of Sudden Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur J Moss, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947310
- Sponsor's protocol ID
- MADIT-RIT
- Acronym
- MADIT-RIT
- Status last verified
- Mar 2013
- First submitted
- 27 Jul 2009
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schuger C, Daubert JP, Brown MW, Cannom D, Estes NA 3rd, Hall WJ, Kayser T, Klein H, Olshansky B, Power KA, Wilber D, Zareba W, Moss AJ. Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol. Ann Noninvasive Electrocardiol. 2012 Jul;17(3):176-85. doi: 10.1111/j.1542-474X.2012.00531.x.
PubMed 22816536Younis A, Heist EK, McNitt S, Aktas MK, Rosero S, Goldenberg I, Kutyifa V. Predictors and outcomes of atrial tachyarrhythmia among patients with implantable defibrillators. Heart Rhythm. 2020 Apr;17(4):553-559. doi: 10.1016/j.hrthm.2019.11.024. Epub 2019 Nov 22.
PubMed 31765809Jackson LR 2nd, Thomas KL, Polonsky B, Zareba W, Lahiri M, Saba S, McNitt S, Schuger C, Daubert JP, Moss AJ, Kutyifa V. Effectiveness of high rate and delayed detection ICD programming by race: A MADIT-RIT substudy. J Cardiovasc Electrophysiol. 2018 Oct;29(10):1418-1424. doi: 10.1111/jce.13693. Epub 2018 Jul 24.
PubMed 29978932Kutyifa V, Daubert JP, Schuger C, Goldenberg I, Klein H, Aktas MK, McNitt S, Stockburger M, Merkely B, Zareba W, Moss AJ. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e001965. doi: 10.1161/CIRCEP.114.001965.
PubMed 26743237Kutyifa V, Daubert JP, Olshansky B, Huang DT, Zhang C, Ruwald AC, McNitt S, Zareba W, Moss AJ, Schuger C. Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis. Heart Rhythm. 2015 Sep;12(9):2030-7. doi: 10.1016/j.hrthm.2015.05.021. Epub 2015 May 19.
PubMed 26001510Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15.
PubMed 25917337Stockburger M, Moss AJ, Olshansky B, Klein H, McNitt S, Schuger C, Daubert JP, Goldenberg I, Ruwald AC, Merkely B, Zareba W, Kutyifa V. Time-dependent risk reduction of ventricular tachyarrhythmias in cardiac resynchronization therapy patients: a MADIT-RIT sub-study. Europace. 2015 Jul;17(7):1085-91. doi: 10.1093/europace/euv008. Epub 2015 Mar 4.
PubMed 25745075Sedlacek K, Ruwald AC, Kutyifa V, McNitt S, Thomsen PEB, Klein H, Stockburger M, Wichterle D, Merkely B, DE LA Concha JF, Swissa M, Zareba W, Moss AJ, Kautzner J, Ruwald MH; MADIT-RIT Investigators. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial. J Cardiovasc Electrophysiol. 2015 Apr;26(4):424-433. doi: 10.1111/jce.12605. Epub 2015 Feb 11.
PubMed 25546486Ruwald AC, Schuger C, Moss AJ, Kutyifa V, Olshansky B, Greenberg H, Cannom DS, Estes NA, Ruwald MH, Huang DT, Klein H, McNitt S, Beck CA, Goldstein R, Brown MW, Kautzner J, Shoda M, Wilber D, Zareba W, Daubert JP. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). Circ Arrhythm Electrophysiol. 2014 Oct;7(5):785-92. doi: 10.1161/CIRCEP.114.001623. Epub 2014 Aug 18.
PubMed 25136077Ruwald MH, Okumura K, Kimura T, Aonuma K, Shoda M, Kutyifa V, Ruwald AC, McNitt S, Zareba W, Moss AJ. Syncope in high-risk cardiomyopathy patients with implantable defibrillators: frequency, risk factors, mechanisms, and association with mortality: results from the multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT-RIT) study. Circulation. 2014 Feb 4;129(5):545-52. doi: 10.1161/CIRCULATIONAHA.113.004196. Epub 2013 Nov 7.
PubMed 24201303Ruwald MH, Zareba W, Jons C, Zhang C, Ruwald AC, Olshansky B, McNitt S, Bloch Thomsen PE, Shoda M, Merkely B, Moss AJ, Kutyifa V. Influence of diabetes mellitus on inappropriate and appropriate implantable cardioverter-defibrillator therapy and mortality in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) Trial. Circulation. 2013 Aug 13;128(7):694-701. doi: 10.1161/CIRCULATIONAHA.113.002472. Epub 2013 Jul 23.
PubMed 23881862Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
PubMed 23131066
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
- ClinicalTrials.gov ID
- NCT00947310
- Acronym / sponsor ID
- MADIT-RIT / MADIT-RIT
- Keywords
- Inappropriate therapy, ICD therapy, Primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 18 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
Detailed description
The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Standard ICD programmingStandard ICD Programming |
| B | Experimental | Device: High rate cutoffHigh rate cutoff |
| C | Experimental | Device: Long delayLong ICD duration delay |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
- Patient in sinus rhythm
- Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
- Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent
Key exclusion criteria (19 listed)
- Patient with an implanted pacemaker or CRT-P
- Patient with existing ICD or CRT-D device components
- Patient with a history of VT or VF
- Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
- Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
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 |
|---|---|---|
| Standard ICD programmingStandard ICD programming | Device | A |
| High rate cutoffProgramming of a high rate cutoff | Device | B |
| Long delayProgramming of a prolonged delay | Device | C |
Primary outcome
Inappropriate ICD Therapy
Time frame: Average of 1.4 years follow-up
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
2 secondary outcomes
All-cause Mortality
Time frame: Average 1.4 years of follow-up
Syncope
Time frame: Average of 1.4 years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22816536Schuger C, Daubert JP, Brown MW, Cannom D, Estes NA 3rd, Hall WJ, Kayser T, Klein H, Olshansky B, Power KA, Wilber D, Zareba W, Moss AJ. Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol. Ann Noninvasive Electrocardiol. 2012 Jul;17(3):176-85. doi: 10.1111/j.1542-474X.2012.00531.x.
- Derived from this study: PubMed 31765809Younis A, Heist EK, McNitt S, Aktas MK, Rosero S, Goldenberg I, Kutyifa V. Predictors and outcomes of atrial tachyarrhythmia among patients with implantable defibrillators. Heart Rhythm. 2020 Apr;17(4):553-559. doi: 10.1016/j.hrthm.2019.11.024. Epub 2019 Nov 22.
- Derived from this study: PubMed 29978932Jackson LR 2nd, Thomas KL, Polonsky B, Zareba W, Lahiri M, Saba S, McNitt S, Schuger C, Daubert JP, Moss AJ, Kutyifa V. Effectiveness of high rate and delayed detection ICD programming by race: A MADIT-RIT substudy. J Cardiovasc Electrophysiol. 2018 Oct;29(10):1418-1424. doi: 10.1111/jce.13693. Epub 2018 Jul 24.
- Derived from this study: PubMed 26743237Kutyifa V, Daubert JP, Schuger C, Goldenberg I, Klein H, Aktas MK, McNitt S, Stockburger M, Merkely B, Zareba W, Moss AJ. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e001965. doi: 10.1161/CIRCEP.114.001965.
- Derived from this study: PubMed 26001510Kutyifa V, Daubert JP, Olshansky B, Huang DT, Zhang C, Ruwald AC, McNitt S, Zareba W, Moss AJ, Schuger C. Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis. Heart Rhythm. 2015 Sep;12(9):2030-7. doi: 10.1016/j.hrthm.2015.05.021. Epub 2015 May 19.
- Derived from this study: PubMed 25917337Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15.
- Derived from this study: PubMed 25745075Stockburger M, Moss AJ, Olshansky B, Klein H, McNitt S, Schuger C, Daubert JP, Goldenberg I, Ruwald AC, Merkely B, Zareba W, Kutyifa V. Time-dependent risk reduction of ventricular tachyarrhythmias in cardiac resynchronization therapy patients: a MADIT-RIT sub-study. Europace. 2015 Jul;17(7):1085-91. doi: 10.1093/europace/euv008. Epub 2015 Mar 4.
- Derived from this study: PubMed 25546486Sedlacek K, Ruwald AC, Kutyifa V, McNitt S, Thomsen PEB, Klein H, Stockburger M, Wichterle D, Merkely B, DE LA Concha JF, Swissa M, Zareba W, Moss AJ, Kautzner J, Ruwald MH; MADIT-RIT Investigators. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial. J Cardiovasc Electrophysiol. 2015 Apr;26(4):424-433. doi: 10.1111/jce.12605. Epub 2015 Feb 11.
- Derived from this study: PubMed 25136077Ruwald AC, Schuger C, Moss AJ, Kutyifa V, Olshansky B, Greenberg H, Cannom DS, Estes NA, Ruwald MH, Huang DT, Klein H, McNitt S, Beck CA, Goldstein R, Brown MW, Kautzner J, Shoda M, Wilber D, Zareba W, Daubert JP. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). Circ Arrhythm Electrophysiol. 2014 Oct;7(5):785-92. doi: 10.1161/CIRCEP.114.001623. Epub 2014 Aug 18.
- Derived from this study: PubMed 24201303Ruwald MH, Okumura K, Kimura T, Aonuma K, Shoda M, Kutyifa V, Ruwald AC, McNitt S, Zareba W, Moss AJ. Syncope in high-risk cardiomyopathy patients with implantable defibrillators: frequency, risk factors, mechanisms, and association with mortality: results from the multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT-RIT) study. Circulation. 2014 Feb 4;129(5):545-52. doi: 10.1161/CIRCULATIONAHA.113.004196. Epub 2013 Nov 7.
- Derived from this study: PubMed 23881862Ruwald MH, Zareba W, Jons C, Zhang C, Ruwald AC, Olshansky B, McNitt S, Bloch Thomsen PE, Shoda M, Merkely B, Moss AJ, Kutyifa V. Influence of diabetes mellitus on inappropriate and appropriate implantable cardioverter-defibrillator therapy and mortality in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) Trial. Circulation. 2013 Aug 13;128(7):694-701. doi: 10.1161/CIRCULATIONAHA.113.002472. Epub 2013 Jul 23.
- Derived from this study: PubMed 23131066Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
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.
Arthur J Moss, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ICD programming, High rate cutoff and Long delay in people with Primary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Inappropriate ICD Therapy (time frame: Average of 1.4 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00947310, which also lists 12 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 8 Aug 2018.