Left Ventricular DysfunctionSMARTMSPNCT03257436

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

A study testing CRT-D in people with Left Ventricular Dysfunction, run by Boston Scientific Corporation at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, multi-center, single arm, post approval study to be conducted in the United States. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Left Ventricular Dysfunction
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: 586 participants
Where: 54 sitesUnited States
Study dates: 5 Jan 2018to 19 Nov 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

Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
Subjects must meet BSC labeled indication for CRT-D implantation.
Subjects must have a functional RA lead and RV lead implanted
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Who cannot join

Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
Subjects with documented history of permanent AF
Subjects with documented permanent complete AV block
Subjects who are expected to receive a heart transplant during the 12 months course of the study
Subjects with documented life expectancy of less than 12 months
Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

Trial locations and contacts

54 sites in 1 country.

City, postcode or hospital

54 sites in 1 country

United States54 sites

AnMed Health Clinical Research
Anderson, South Carolina, 29621
Foothill Cardiology Medical Group
Arcadia, California, 91007
Augusta University
Augusta, Georgia, 30912
MedStar Heart and Vascular Institute
Baltimore, Maryland, 21237
Heartplace, PA
Bedford, Texas, 76021
Billings Clinic
Billings, Montana, 59101
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
University of Virginia
Charlottesville, Virginia, 22908
Chula Vista Cardiac Center
Chula Vista, California, 91910
Trihealth- Good Samaritan & Bethesda North Hospitals
Cincinnati, Ohio, 45220
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Delray Medical Center
Delray Beach, Florida, 33484
Ascension St. John Hospital & Medical Center
Detroit, Michigan, 48236
Durham VA medical Center
Durham, North Carolina, 27705
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Parkview Hospital Inc
Fort Wayne, Indiana, 46845
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Hackensack University Medical Canter
Hackensack, New Jersey, 07601
UT Health
Houston, Texas, 77030
St. Mary's Medical Center
Huntington, West Virginia, 25702
UMMC- Division of Cardiology
Jackson, Mississippi, 39216
UF Health Jacksonville
Jacksonville, Florida, 32209
Cardiology Associates of NEA
Jonesboro, Arkansas, 72401
University of Kansas Medical Center
Kansas City, Kansas, 66160
St. Lukes Hospital
Kansas City, Missouri, 64111
Florida Hospital Waterman
Lake Mary, Florida, 32746
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Norton Heart Specialist
Louisville, Kentucky, 40205
Carient Heart and Vascular
Manassas, Virginia, 20109
Mobile Infirmary Medical Center
Mobile, Alabama, 36604
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Sentara Norfolk General
Norfolk, Virginia, 23507
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, 68114
Desert Heart Rhythm Consultants
Palm Springs, California, 92262
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Phoenix Cardiovascular Group
Phoenix, Arizona, 85006
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
WakeMed
Raleigh, North Carolina, 27610
Rapid City Regional Health
Rapid City, South Dakota, 75501
St. Mary's of Michigan Research Institute at Covenant Medical Ceter
Saginaw, Michigan, 48601
Salem Health
Salem, Oregon, 97301
University of Utah
Salt Lake City, Utah, 84132
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71105
Tallahassee Research Institute
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 10467
Carle Foundation Hospital
Urbana, Illinois, 61801
Cardiology Associates Medical Group
Ventura, California, 93003
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Berk Cardiologists
Wyomissing, Pennsylvania, 19610
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501

Other trials in United States

About this study

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Read the detailed description

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

Conditions: Left Ventricular Dysfunction
Being tested: CRT-D
Keywords: Pacing
Medical subject headings: Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRT-DDevice
Left Ventricular MultiSite Pacing

Study groups in NCT03257436
Study group	Role	What they receive
Single Arm	Other	General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. Receives: Device: CRT-D

What is being measured

The primary outcome is the main question the study is designed to answer.

LV MSP Feature Related Complication-Free Rate
Proportion of subjects free from LVMSP feature related complications at 12 months
Measured: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
Measured: 12 Month Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201819 Nov 2020

First posted22 Aug 2017
Study start5 Jan 2018
Primary completion19 Nov 2020
Study completion19 Nov 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.
Other trials for Left Ventricular DysfunctionStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 586 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03257436
Sponsor's protocol ID: 92050975
Acronym: SMARTMSP
Status last verified: Dec 2021
First submitted: 18 Aug 2017
Last updated: 3 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Recruiting
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 3
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block

All Left Ventricular Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
ClinicalTrials.gov ID: NCT03257436
Acronym / sponsor ID: SMARTMSP / 92050975
Conditions: Left Ventricular Dysfunction
Keywords: Pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 586 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 5 Jan 2018 (actual)
Primary completion: 19 Nov 2020 (actual)
Study completion: 19 Nov 2020 (actual)
First posted: 22 Aug 2017 (actual)
Results: Posted 3 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Other	Device: CRT-DGeneral population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
Subjects must meet BSC labeled indication for CRT-D implantation.
Subjects must have a functional RA lead and RV lead implanted
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol

Key exclusion criteria (7 listed)

Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
Subjects with documented history of permanent AF
Subjects with documented permanent complete AV block
Subjects who are expected to receive a heart transplant during the 12 months course of the study

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-DLeft Ventricular MultiSite Pacing	Device	Single Arm

Primary outcome

LV MSP Feature Related Complication-Free Rate
Time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Proportion of subjects free from LVMSP feature related complications at 12 months
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Time frame: 12 Month Follow Up
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.

Results and safety

Results posted to the registry on 3 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	584	489

Primary outcome: LV MSP Feature Related Complication-Free Rate

Time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Single Arm n = 102
Value	99 (94.1 to NA)

Single Arm: Kaplan Meir Methodology: 99

Population analysed: Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit

Primary outcome: Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months

Time frame: 12 Month Follow Up. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Single Arm n = 78
Value	51.3 (41.4 to NA)

Single Arm: Proportion: 51.3

Population analysed: Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved \>93% LVa and LVb pacing

Adverse events

Time frame: Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	131 of 584 (22.4%)	72 of 584 (12.3%)	19 of 584

Limitations and caveats (from the sponsor): Because the study was not designed to randomize subjects to conventional CRT or LV MSP, the potential incremental benefit of LV MSP cannot be quantified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Left Ventricular Dysfunction

Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Recruiting
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 3
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block

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.

Saba Samir principal investigator

University of Pittsburgh Medical Center

54 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CRT-D in people with Left Ventricular Dysfunction, run by Boston Scientific Corporation at 54 sites 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 6 inclusion and 7 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites 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 3 Jan 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?

LV MSP Feature Related Complication-Free Rate (time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.). The study lists 2 primary outcomes in all. 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 NCT03257436.

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 3 Jan 2022.