Heart FailurePhase 4SMART-AVNCT00677014
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
A Phase 4 study testing AV Delay programming through cardiac resynchronization therapy in people with Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AV Delay programming through cardiac resynchronization therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
- Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
- Patients who are on optimal and stable pharmacologic therapy
- Patients who are expected to be in sinus rhythm at the time of implant
- Patients who have a life expectancy of more than 360 days, per physician's discretion
- Patients who are geographically stable and willing to comply with the required follow-up schedule
- Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients who have previously received cardiac resynchronization therapy
- Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
- Patients who are pregnant or planning to become pregnant during the study
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Virginia
Richmond, Virginia, 23298-0053
About this study
Official title: SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.
Read the detailed description
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.
- Conditions
- Heart Failure
- Being tested
- AV Delay programming through cardiac resynchronization therapy
- Keywords
- Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV Delay programming through cardiac resynchronization therapyDevice
All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
AV Delay programming through cardiac resynchronization therapyDevice
All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
AV Delay programming through cardiac resynchronization therapyDevice
All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
| Study group | Role | What they receive |
|---|---|---|
| Echo optimized AV delay | Active comparator | Echo optimized AV delay Receives: Device: AV Delay programming through cardiac resynchronization therapy |
| Algorithm optimized AV delay | Active comparator | Algorithm optimized AV delay Receives: Device: AV Delay programming through cardiac resynchronization therapy |
| Fixed AV Delay | Active comparator | Fixed AV Delay Receives: Device: AV Delay programming through cardiac resynchronization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular End-systolic Volume (LVESV)
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
Measured: 6 months
Secondary outcomes (1)
Secondary Endpoints Will Include Structural and Functional Measures
Measured: Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
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 (13)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CRM Clinical Affairs, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677014
- Sponsor's protocol ID
- CR-CA-050508-H
- Acronym
- SMART-AV
- Status last verified
- Apr 2013
- First submitted
- 9 May 2008
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993.
PubMed 10368116Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, Klein HU. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol. 2002 Apr 3;39(7):1163-9. doi: 10.1016/s0735-1097(02)01727-8.
PubMed 11923041Inoue N, Ishikawa T, Sumita S, Nakagawa T, Kobayashi T, Matsushita K, Matsumoto K, Ohkusu Y, Taima M, Kosuge M, Uchino K, Kimura K, Umemura S. Long-term follow-up of atrioventricular delay optimization in patients with biventricular pacing. Circ J. 2005 Feb;69(2):201-4. doi: 10.1253/circj.69.201.
PubMed 15671613Meisner JS, McQueen DM, Ishida Y, Vetter HO, Bortolotti U, Strom JA, Frater RW, Peskin CS, Yellin EL. Effects of timing of atrial systole on LV filling and mitral valve closure: computer and dog studies. Am J Physiol. 1985 Sep;249(3 Pt 2):H604-19. doi: 10.1152/ajpheart.1985.249.3.H604.
PubMed 3839979Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol. 2006 Jun;29(6):564-8. doi: 10.1111/j.1540-8159.2006.00402.x.
PubMed 16784420Steendijk P, Tulner SA, Bax JJ, Oemrawsingh PV, Bleeker GB, van Erven L, Putter H, Verwey HF, van der Wall EE, Schalij MJ. Hemodynamic effects of long-term cardiac resynchronization therapy: analysis by pressure-volume loops. Circulation. 2006 Mar 14;113(10):1295-304. doi: 10.1161/CIRCULATIONAHA.105.540435. Epub 2006 Mar 6.
PubMed 16520415Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, Ehlermann P, Remppis A, Katus HA, Kuecherer HF. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol. 2007 Feb 14;115(3):318-25. doi: 10.1016/j.ijcard.2006.03.015. Epub 2006 Aug 7.
PubMed 16891011Tournoux FB, Alabiad C, Fan D, Chen AA, Chaput M, Heist EK, Mela T, Mansour M, Reddy V, Ruskin JN, Picard MH, Singh JP. Echocardiographic measures of acute haemodynamic response after cardiac resynchronization therapy predict long-term clinical outcome. Eur Heart J. 2007 May;28(9):1143-8. doi: 10.1093/eurheartj/ehm050. Epub 2007 Apr 21.
PubMed 17449877Vidal B, Sitges M, Marigliano A, Delgado V, Diaz-Infante E, Azqueta M, Tamborero D, Tolosana JM, Berruezo A, Perez-Villa F, Pare C, Mont L, Brugada J. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am J Cardiol. 2007 Sep 15;100(6):1002-6. doi: 10.1016/j.amjcard.2007.04.046. Epub 2007 Jul 5.
PubMed 17826387Kedia N, Ng K, Apperson-Hansen C, Wang C, Tchou P, Wilkoff BL, Grimm RA. Usefulness of atrioventricular delay optimization using Doppler assessment of mitral inflow in patients undergoing cardiac resynchronization therapy. Am J Cardiol. 2006 Sep 15;98(6):780-5. doi: 10.1016/j.amjcard.2006.04.017. Epub 2006 Jul 28.
PubMed 16950184Howell S, Stivland TM, Stein K, Ellenbogen K, Tereshchenko LG. Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial. BMJ Open. 2021 Oct 27;11(10):e049017. doi: 10.1136/bmjopen-2021-049017.
PubMed 34706949Howell SJ, Stivland T, Stein K, Ellenbogen KA, Tereshchenko LG. Using Machine-Learning for Prediction of the Response to Cardiac Resynchronization Therapy: The SMART-AV Study. JACC Clin Electrophysiol. 2021 Dec;7(12):1505-1515. doi: 10.1016/j.jacep.2021.06.009. Epub 2021 Aug 25.
PubMed 34454883Spinale FG, Meyer TE, Stolen CM, Van Eyk JE, Gold MR, Mittal S, DeSantis SM, Wold N, Beshai JF, Stein KM, Ellenbogen KA; SMART-AV Trial Investigators. Development of a biomarker panel to predict cardiac resynchronization therapy response: Results from the SMART-AV trial. Heart Rhythm. 2019 May;16(5):743-753. doi: 10.1016/j.hrthm.2018.11.026. Epub 2018 Nov 24.
PubMed 30476543
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00677014
- Acronym / sponsor ID
- SMART-AV / CR-CA-050508-H
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 30 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.
Detailed description
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Echo optimized AV delay | Active comparator | Device: AV Delay programming through cardiac resynchronization therapyEcho optimized AV delay |
| Algorithm optimized AV delay | Active comparator | Device: AV Delay programming through cardiac resynchronization therapyAlgorithm optimized AV delay |
| Fixed AV Delay | Active comparator | Device: AV Delay programming through cardiac resynchronization therapyFixed AV Delay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
- Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
- Patients who are on optimal and stable pharmacologic therapy
- Patients who are expected to be in sinus rhythm at the time of implant
- Patients who have a life expectancy of more than 360 days, per physician's discretion
Key exclusion criteria (8 listed)
- Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients who have previously received cardiac resynchronization therapy
- Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
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 |
|---|---|---|
| AV Delay programming through cardiac resynchronization therapyAll subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. | Device | Fixed AV Delay |
| AV Delay programming through cardiac resynchronization therapyAll subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. | Device | Algorithm optimized AV delay |
| AV Delay programming through cardiac resynchronization therapyAll subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm. | Device | Echo optimized AV delay |
Primary outcome
Left Ventricular End-systolic Volume (LVESV)
Time frame: 6 months
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
1 secondary outcome
Secondary Endpoints Will Include Structural and Functional Measures
Time frame: Chronic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10368116Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993.
- Background: PubMed 11923041Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, Klein HU. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol. 2002 Apr 3;39(7):1163-9. doi: 10.1016/s0735-1097(02)01727-8.
- Background: PubMed 15671613Inoue N, Ishikawa T, Sumita S, Nakagawa T, Kobayashi T, Matsushita K, Matsumoto K, Ohkusu Y, Taima M, Kosuge M, Uchino K, Kimura K, Umemura S. Long-term follow-up of atrioventricular delay optimization in patients with biventricular pacing. Circ J. 2005 Feb;69(2):201-4. doi: 10.1253/circj.69.201.
- Background: PubMed 3839979Meisner JS, McQueen DM, Ishida Y, Vetter HO, Bortolotti U, Strom JA, Frater RW, Peskin CS, Yellin EL. Effects of timing of atrial systole on LV filling and mitral valve closure: computer and dog studies. Am J Physiol. 1985 Sep;249(3 Pt 2):H604-19. doi: 10.1152/ajpheart.1985.249.3.H604.
- Background: PubMed 16784420Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol. 2006 Jun;29(6):564-8. doi: 10.1111/j.1540-8159.2006.00402.x.
- Background: PubMed 16520415Steendijk P, Tulner SA, Bax JJ, Oemrawsingh PV, Bleeker GB, van Erven L, Putter H, Verwey HF, van der Wall EE, Schalij MJ. Hemodynamic effects of long-term cardiac resynchronization therapy: analysis by pressure-volume loops. Circulation. 2006 Mar 14;113(10):1295-304. doi: 10.1161/CIRCULATIONAHA.105.540435. Epub 2006 Mar 6.
- Background: PubMed 16891011Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, Ehlermann P, Remppis A, Katus HA, Kuecherer HF. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol. 2007 Feb 14;115(3):318-25. doi: 10.1016/j.ijcard.2006.03.015. Epub 2006 Aug 7.
- Background: PubMed 17449877Tournoux FB, Alabiad C, Fan D, Chen AA, Chaput M, Heist EK, Mela T, Mansour M, Reddy V, Ruskin JN, Picard MH, Singh JP. Echocardiographic measures of acute haemodynamic response after cardiac resynchronization therapy predict long-term clinical outcome. Eur Heart J. 2007 May;28(9):1143-8. doi: 10.1093/eurheartj/ehm050. Epub 2007 Apr 21.
- Background: PubMed 17826387Vidal B, Sitges M, Marigliano A, Delgado V, Diaz-Infante E, Azqueta M, Tamborero D, Tolosana JM, Berruezo A, Perez-Villa F, Pare C, Mont L, Brugada J. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am J Cardiol. 2007 Sep 15;100(6):1002-6. doi: 10.1016/j.amjcard.2007.04.046. Epub 2007 Jul 5.
- Background: PubMed 16950184Kedia N, Ng K, Apperson-Hansen C, Wang C, Tchou P, Wilkoff BL, Grimm RA. Usefulness of atrioventricular delay optimization using Doppler assessment of mitral inflow in patients undergoing cardiac resynchronization therapy. Am J Cardiol. 2006 Sep 15;98(6):780-5. doi: 10.1016/j.amjcard.2006.04.017. Epub 2006 Jul 28.
- Derived from this study: PubMed 34706949Howell S, Stivland TM, Stein K, Ellenbogen K, Tereshchenko LG. Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial. BMJ Open. 2021 Oct 27;11(10):e049017. doi: 10.1136/bmjopen-2021-049017.
- Derived from this study: PubMed 34454883Howell SJ, Stivland T, Stein K, Ellenbogen KA, Tereshchenko LG. Using Machine-Learning for Prediction of the Response to Cardiac Resynchronization Therapy: The SMART-AV Study. JACC Clin Electrophysiol. 2021 Dec;7(12):1505-1515. doi: 10.1016/j.jacep.2021.06.009. Epub 2021 Aug 25.
- Sponsor websiteLink provided by the sponsor.
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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.
CRM Clinical Affairs study director
Boston Scientific Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AV Delay programming through cardiac resynchronization therapy in people with Heart Failure, 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 7 inclusion and 8 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 24 Apr 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2012). 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?
Left Ventricular End-systolic Volume (LVESV) (time frame: 6 months). 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 NCT00677014, which also lists 13 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 24 Apr 2013.