An observational study in Heart Failure, sponsored by Boston Scientific Corporation. Terminated at 97 sites in United States. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by Boston Scientific Corporation · Observational
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 1,308 is above the median of 200 across 1,680 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 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.
The population will be a broad base representative of those recieving the ACUITY Spiral lead.
Exclusion Criteria:
Patients successfully implanted with the ACUITY Spiral Lead
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead
Chronic Left Ventricular Lead-related Complication Free Rate
Time frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
| Milestone | Implants |
|---|---|
| Started | 1308 |
| Completed | 250 |
| Not completed | 1058 |
| Withdrew: Death | 269 |
| Withdrew: Lost to follow-up | 72 |
| Withdrew: Physician decision | 36 |
| Withdrew: Protocol violation | 134 |
| Withdrew: Registry conclusion | 186 |
| Withdrew: Product removed from service | 94 |
| Withdrew: Patient refused to participate further | 116 |
| Withdrew: Closure of study location | 60 |
| Withdrew: Patient changed care provider/moved | 91 |
| Percent free from event | Implants |
|---|---|
| Chronic Left Ventricular Lead-related Complication Free Rate | 95.3 (94.0 to NA) |
Collected over Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implants | 269/1,303 (20.6%) | 117/1,303 (9%) | 131/1,303 (10.1%) |
| Event | Implants |
|---|---|
| Lead Dislodgment, Left VentricularCardiac disorders | 29/1303 |
| Threshold Related, Left VentricularCardiac disorders | 19/1303 |
| Extracardiac Stimulation, Left VentricularCardiac disorders | 10/1303 |
| Infection, Procedure relatedSurgical and medical procedures | 10/1303 |
| Erosion/MigrationSurgical and medical procedures | 9/1303 |
| Lead Dislodgment, Atrial LeadCardiac disorders | 6/1303 |
| Inability to provide therapy, pulse generatorSurgical and medical procedures | 5/1303 |
| Lead Dislodgment, Right VentricularSurgical and medical procedures | 5/1303 |
| Threshold Related, Right VentricularCardiac disorders | 5/1303 |
| Impedance Related, Right VentricularCardiac disorders | 3/1303 |
| Event | Implants |
|---|---|
| Extracardiac Stimulation, Left VentricularCardiac disorders | 77/1303 |
| Inappropriate Tachy Therapy, Pulse GeneratorCardiac disorders | 28/1303 |
| Threshold Related, Left VentricularCardiac disorders | 26/1303 |
Baseline data includes data on the patients that received an implant or underwent an attempted implant. This does not include intent patients who were consented but did not participate in the trial and did not undergo anesthesia.
| Age, Categorical(Participants) | Implants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 387 |
| >=65 years | 916 |
| Sex: Female, Male(Participants) | Implants |
|---|---|
| Female | 357 |
| Male | 946 |
| Race/Ethnicity, Customized(Participants) | Implants |
|---|---|
| American Indian or Alaska Native | 6 |
| Asian | 16 |
| Native Hawaiian or Pacific Islander | 5 |
| Black or African American | 124 |
| White | 1065 |
| Bosnian | 1 |
| East Indian | 1 |
| Filipino | 1 |
| Middle Eastern | 1 |
| Russian | 1 |
| Unknown | 29 |
| Hispanic or Latino | 52 |
| Vietnamese | 1 |
| Region of Enrollment(participants) | Implants |
|---|---|
| Puerto Rico | 2 |
| United States | 1301 |
| QRS Duration(Milliseconds) | Implants |
|---|---|
| Mean | 150 ± 31 |
| PR Interval(milliseconds) | Implants |
|---|---|
| Mean | 183 ± 55 |
| Left Ventricular Ejection Fraction(percentage) | Implants |
|---|---|
| Mean | 26.8 ± 7.9 |
| Arrhythmia Conduction Disorder(Participants) | Implants |
|---|---|
| Left Bundle Branch Block | 691 |
| Right Bundle Branch Block | 149 |
| Nonspecific Intraventricular Delay | 228 |
| No Arrhythmia Conduction Disorder | 140 |
| Unknown | 77 |
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Plan to share: No
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