An interventional study of CRT-D in Left Ventricular Dysfunction, sponsored by Boston Scientific Corporation. Completed at 54 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Other
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
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.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's enrollment of 586 is above the median of 100 across 151 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
Device: CRT-D
Left Ventricular MultiSite Pacing
LV MSP Feature Related Complication-Free Rate
Proportion of subjects free from LVMSP feature related complications at 12 months
Time frame: 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.
Time frame: 12 Month Follow Up
| Milestone | Single Arm |
|---|---|
| Started | 584 |
| Completed | 489 |
| Not completed | 95 |
| Withdrew: Withdrawal by subject | 76 |
| Withdrew: Death | 19 |
Proportion of subjects free from LVMSP feature related complications at 12 months
| percentage of participants | Single Arm |
|---|---|
| LV MSP Feature Related Complication-Free Rate | 99 (94.1 to NA) |
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.
| percentage of participants | Single Arm |
|---|---|
| Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | 51.3 (41.4 to NA) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | 19/584 (3.3%) | 131/584 (22.4%) | 72/584 (12.3%) |
| Event | Single Arm |
|---|---|
| Multiple heart failure symptomsCardiac disorders | 22/584 |
| Dyspnea - Heart failureCardiac disorders | 15/584 |
| RenalRenal and urinary disorders | 14/584 |
| GastrointestinalGastrointestinal disorders | 12/584 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 10/584 |
| Heart failure symptoms - UnspecifiedEye disorders | 8/584 |
| Ventricular Tachycardia (VT)/Monomorphic VTCardiac disorders | 8/584 |
| GenitourinaryRenal and urinary disorders | 7/584 |
| Chest Pain - OtherGeneral disorders | 5/584 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/584 |
| Event | Single Arm |
|---|---|
| Extracardiac stimulation - LV LeadProduct Issues | 21/584 |
| Pacemaker Mediated Tachycardia - PG System TherapyProduct Issues | 8/584 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 3/584 |
| Elevated threshold - LV LeadProduct Issues | 3/584 |
| Ventricular Tachycardia (VT)/Monomorphic VTCardiac disorders | 2/584 |
| GastrointestinalGastrointestinal disorders | 2/584 |
| Hematoma - Pocket (<=30 days post-implant)Injury, poisoning and procedural complications | 2/584 |
| Post-surgical infection (<=30 days post-implant)Injury, poisoning and procedural complications | 2/584 |
| Post-surgical wound discomfort/bruising/swellingInjury, poisoning and procedural complications | 2/584 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 2/584 |
Total subjects with non-missing values
| Age, Continuous(Years) | Single Arm |
|---|---|
| Mean | 66.7 ± 11 |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 211 |
| Male | 372 |
| Race (NIH/OMB)(Participants) | Single Arm |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 95 |
| White | 460 |
| More than one race | 10 |
| Unknown or Not Reported | 14 |
| Region of Enrollment(participants) | Single Arm |
|---|---|
| United States | 583 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Nov 2020, 34 months.
Results were first posted in Jan 2022, 1 year 1 month after primary completion.
Of 34 interventional studies with no phase under Ventricular Dysfunction, Left, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 86. This study's 34 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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