Heart FailureSMART CRTNCT03089281
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
A study testing CRT-D in people with Heart Failure, run by Boston Scientific Corporation at 72 sites in 11 countries.
Trial summary
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 699 participants
- Where
- 72 sitesin 11 countries
- Study dates
- 1 Aug 2017to 15 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
- In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
- Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
- Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
- Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
- Subject is willing and capable of providing informed consent
- Subject is willing and capable of complying with visits and procedures as defined by this protocol
Who cannot join
- Subjects with documented permanent complete AV block
- Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
- Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
- Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
- Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
- Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
Show all 9Show fewer
- Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
- Women of childbearing potential who are or plan to become pregnant during the course of the trial
- Subjects currently requiring dialysis
Trial locations and contacts
72 sites in 11 countries.
72 sites in 11 countries
United States41 sites
Emory University Hospital
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Affinity Hospital, LLC d/b/a Granview Medical Center
Birmingham, Alabama, 35243
New York Methodist Hospital
Brooklyn, New York, 11215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
The University of Chicago
Chicago, Illinois, 60637
The Ohio Health Research Institute- Grant Medical Center
Columbus, Ohio, 43215
Dallas VA Research Corporation
Dallas, Texas, 75216
Geisinger Clinic
Danville, Pennsylvania, 17822
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Southcoast Health
Fall River, Massachusetts, 02720
Glendale Adventist Medical Center
Glendale, California, 91206
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Heart Center Research LLC
Huntsville, Alabama, 35801
University of Iowa Hospitals
Iowa City, Iowa, 52242
Baptist Health Research Institute
Jacksonville, Florida, 32207
Cardiology Associates of NE Arkansas
Jonesboro, Arkansas, 72401
Watson Clinic Center for Research, Inc
Lakeland, Florida, 33805
Baptist Health Lexington
Lexington, Kentucky, 40503
The International Heart Institute on Montana Foundation
Missoula, Montana, 59802
Christiana Care Health Services
Newark, Delaware, 19718
Heart Group at Deaconness Hospital
Newburgh, Indiana, 47630
The Valley Hospital
Paramus, New Jersey, 07652
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Providence Heart Institute
Portland, Oregon, 97225
Pottstown Medical Specialist, Inc
Pottstown, Pennsylvania, 19464
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Cardiovascular Institute of Michigan
Roseville, Michigan, 48066
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
Foundation for Advancing Veterans' Health Research
San Antonio, Texas, 78229
North Central Heart
Sioux Falls, South Dakota, 57108
St. John's Hospital
Springfield, Illinois, 62701
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Winter Haven Hospital
Winter Haven, Florida, 33881
Trinity Health Michigan d/b/a Michigan Heart
Ypsilanti, Michigan, 48197
France7 sites
Centre hospitalier du pays d'Aix
Aix-en-Provence, 13616
CHU Grenoble
Grenoble, 38043
CHRU de Lille
Lille, 59037
Hopital Saint Philibert
Lille, 59160
CHRU Hopital Pontchaillou
Rennes, 35000
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
Rouen, 76031
Centre Hôpital Universitaire Rangueil
Toulouse, 31059
United Kingdom6 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
University Hospital of Wales
Cardiff, CF144XW
Hammersmith Hospital
London, W12 0HS
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Nottingham University Hospital
Nottingham, NG5 1PB
Southampton University Hospital
Southampton, SO16 6YD
Germany5 sites
Unfalkrankenhaus Marzahn
Berlin, 12683
University of Berlin, Charite Virchow Standort
Berlin, 13353
Uni Jena
Jena, 07747
Krankenhaus Landshut-Achdorf
Landshut, 84036
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, 39120
Japan4 sites
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8562
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
Shinshu University Hospital
Nagano
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666
Spain3 sites
Hospital Infanta Cristina
Badajoz, Extremadura, 06080
Hospital 12 de Octubre Madrid
Madrid, 28041
Hospital Universitario La Fe
Valencia, 46026
Italy2 sites
Ospedale S. Orsola - Malpighi
Bologna, 40138
Azienda Sanitaria Universtitaria Integrata di Trieste
Trieste, 34129
Canada1 site
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec
About this study
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Read the detailed description
The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).
- Conditions
- Heart Failure
- Being tested
- CRT-D
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.
| Study group | Role | What they receive |
|---|---|---|
| SmartDelay™ algorithm | Other | Subjects programmed with AV Delay and pacing chamber determined by SmartDelay Receives: Device: CRT-D |
| Fixed AV Delay with BiV pacing | Other | Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing Receives: Device: CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT Response
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.
Measured: Pre-Implant baseline to 6 months
Secondary outcomes (6)
Change in Left Ventricular End Systolic Volume (Absolute Change)
Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.
Measured: Implant to 6 Months
Change in Left Ventricular End Systolic Volume (Relative Change)
Comparing relative changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A negative change in LVESV is considered an improvement.
Measured: Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Absolute Change)
Comparing absolute changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in % of blood ejected during LV contraction. A positive change in LVEF is considered an improvement.
Measured: Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Relative Change)
Comparing relative changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A positive change in LVEF is considered an improvement.
Measured: Implant to 6 Months
Clinical Composite Score (CCS)
Th CCS combines four metrics: all-cause mortality, heart failure hospitalization (HFH), New York Heart Association (NYHA) Class, and quality of life as measured with the patient global assessment (GA) instrument.
The CCS categorizes each subject into one of three groups: Improved, Unchanged or Worsened.
- Improved: Subjects that survived without a HFH through the 6-month visit window and had either an improvement in NYHA class or responded to GA with "much better" or "very much better".
- Unchanged: All patients that reached the end of 6-month visit window that were not categorized as either "Improved" or "Worsened".
- Worsened: Subjects that died or had HFH within 6-month visit window or had either a worsening in NYHA class or responded to GA with "much worse" or "very much worse".
Measured: Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The KCCQ is a disease-specific instrument for monitoring the health status and quality of life of subjects with congestive heart failure. It includes a total of 23 items that assess quality of life in the following domains: physical function, symptom frequency and severity, symptom stability, self-efficacy and knowledge, social function, and overall quality of life. These domains can be combined into a functional status summary score (derived from the physical function and symptom scales) and an overall summary score which combines the physical function, symptom, social function and quality of life domains.
KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Measured: Implant to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Aug 2017
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
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 (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael R. Gold, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089281
- Sponsor's protocol ID
- C2067
- Acronym
- SMART CRT
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2017
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gold MR, Ellenbogen KA, Leclercq C, Lowy J, Rials SJ, Shoda M, Tomassoni G, Issa Z, Sarrazin JF, Jennings JM, Nair DG, Wold N, Yong P, Harbin MM, Stein KM, Auricchio A. Effects of Atrioventricular Optimization on Left Ventricular Reverse Remodeling With Cardiac Resynchronization Therapy: Results of the SMART-CRT Trial. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011714. doi: 10.1161/CIRCEP.122.011714. Epub 2023 May 15.
PubMed 37183700
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03089281
- Acronym / sponsor ID
- SMART CRT / C2067
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 5 Apr 2022
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 is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Detailed description
The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartDelay™ algorithm | Other | Device: CRT-DSubjects programmed with AV Delay and pacing chamber determined by SmartDelay |
| Fixed AV Delay with BiV pacing | Other | Device: CRT-DSubjects programmed with a Fixed AV Delay of 120ms with BiV pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
- In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
- Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
- Subject is willing and capable of providing informed consent
- Subject is willing and capable of complying with visits and procedures as defined by this protocol
Key exclusion criteria (9 listed)
- Subjects with documented permanent complete AV block
- Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
- Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
- Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
- Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
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 |
|---|---|---|
| CRT-DCommercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system. | Device | Fixed AV Delay with BiV pacing, SmartDelay™ algorithm |
Primary outcome
CRT Response
Time frame: Pre-Implant baseline to 6 months
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.
6 secondary outcomes
Change in Left Ventricular End Systolic Volume (Absolute Change)
Time frame: Implant to 6 Months
Change in Left Ventricular End Systolic Volume (Relative Change)
Time frame: Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Absolute Change)
Time frame: Implant to 6 Months
Change in Left Ventricular Ejection Fraction (Relative Change)
Time frame: Implant to 6 Months
Clinical Composite Score (CCS)
Time frame: Implant to 6 Months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Implant to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37183700Gold MR, Ellenbogen KA, Leclercq C, Lowy J, Rials SJ, Shoda M, Tomassoni G, Issa Z, Sarrazin JF, Jennings JM, Nair DG, Wold N, Yong P, Harbin MM, Stein KM, Auricchio A. Effects of Atrioventricular Optimization on Left Ventricular Reverse Remodeling With Cardiac Resynchronization Therapy: Results of the SMART-CRT Trial. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011714. doi: 10.1161/CIRCEP.122.011714. Epub 2023 May 15.
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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.
Michael R. Gold, MD principal investigator
Medical University of South Carolina
72 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-D in people with Heart Failure, run by Boston Scientific Corporation at 72 sites in 11 countries.
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 9 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, France, United Kingdom, Germany, Japan and 6 more countries. 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 5 Apr 2022). 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?
CRT Response (time frame: Pre-Implant baseline to 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 NCT03089281, which also lists 1 linked publication.
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 5 Apr 2022.