Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00955708
Previous Study | Return to List | Next Study

Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00955708
Recruitment Status : Terminated (Early termination was granted by FDA based on study results meeting the post approval requirements.)
First Posted : August 10, 2009
Results First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Heart Failure
Intervention Device: ACUITY Spiral Left Ventricular Lead
Enrollment 1308
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Implants
Hide Arm/Group Description

Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead

ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead

Period Title: Overall Study
Started 1308
Completed 250
Not Completed 1058
Reason Not Completed
Death             269
Lost to Follow-up             72
Physician Decision             36
Protocol Violation             134
Registry Conclusion             186
Product removed from service             94
Patient Refused to participate further             116
Closure of study location             60
Patient changed care provider/moved             91
Arm/Group Title Implants
Hide Arm/Group Description

Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead

ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead

Overall Number of Baseline Participants 1303
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1303 participants
<=18 years
0
   0.0%
Between 18 and 65 years
387
  29.7%
>=65 years
916
  70.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1303 participants
Female
357
  27.4%
Male
946
  72.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 1303 participants
6
   0.5%
Asian Number Analyzed 1303 participants
16
   1.2%
Native Hawaiian or Pacific Islander Number Analyzed 1303 participants
5
   0.4%
Black or African American Number Analyzed 1303 participants
124
   9.5%
White Number Analyzed 1303 participants
1065
  81.7%
Bosnian Number Analyzed 1303 participants
1
   0.1%
East Indian Number Analyzed 1303 participants
1
   0.1%
Filipino Number Analyzed 1303 participants
1
   0.1%
Middle Eastern Number Analyzed 1303 participants
1
   0.1%
Russian Number Analyzed 1303 participants
1
   0.1%
Unknown Number Analyzed 1303 participants
29
   2.2%
Hispanic or Latino Number Analyzed 1303 participants
52
   4.0%
Vietnamese Number Analyzed 1303 participants
1
   0.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Puerto Rico Number Analyzed 1303 participants
2
United States Number Analyzed 1303 participants
1301
QRS Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 1254 participants
150  (31)
[1]
Measure Analysis Population Description: QRS Duration value unavailable for 49 subjects
PR Interval   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliseconds
Number Analyzed 958 participants
183  (55)
[1]
Measure Analysis Population Description: PR Interval (ms) unavailable for 354 subjects
Left Ventricular Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 1278 participants
26.8  (7.9)
[1]
Measure Analysis Population Description: Left Ventricular Ejection Fraction unavailable for 25 subjects
Arrhythmia Conduction Disorder   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1285 participants
Left Bundle Branch Block
691
  53.8%
Right Bundle Branch Block
149
  11.6%
Nonspecific Intraventricular Delay
228
  17.7%
No Arrhythmia Conduction Disorder
140
  10.9%
Unknown
77
   6.0%
[1]
Measure Analysis Population Description: Arrhythmia Conduction Disorder was unavailable for 23 subjects
1.Primary Outcome
Title Chronic Left Ventricular Lead-related Complication Free Rate
Hide Description [Not Specified]
Time Frame Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implants
Hide Arm/Group Description:

Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead

ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead

Overall Number of Participants Analyzed 1303
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent free from event
95.3 [1] 
(94.0 to NA)
[1]
Interval is only calculated for the lower end. The method is defined as the lower one-sided 95% confidence interval compared to the confidence boundary of 92.5%.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Implants
Comments The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.
Type of Statistical Test Other
Comments Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.
Method of Estimation Estimation Parameter Kaplan-Meier Rate
Estimated Value 95.3
Confidence Interval (1-Sided) 95.0%
94.0
Estimation Comments The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Implants
Comments The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.
Type of Statistical Test Other
Comments Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.
Method of Estimation Estimation Parameter Kaplan-Meier Rate
Estimated Value 100
Confidence Interval (1-Sided) 95%
100
Estimation Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
 
Arm/Group Title Implants
Hide Arm/Group Description

Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead

ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead

All-Cause Mortality
Implants
Affected / at Risk (%)
Total   269/1303 (20.64%)    
Hide Serious Adverse Events
Implants
Affected / at Risk (%) # Events
Total   117/1303 (8.98%)    
Blood and lymphatic system disorders   
Hematoma   2/1303 (0.15%)  2
Cardiac disorders   
Extracardiac Stimulation, Left Ventricular   10/1303 (0.77%)  10
Lead Dislodgment, Left Ventricular   29/1303 (2.23%)  29
Threshold Related, Left Ventricular   19/1303 (1.46%)  19
Ventricular Tachycardia   2/1303 (0.15%)  2
Accelerated Ventricular Rhythm   2/1303 (0.15%)  2
Atrial Arrhythmia   1/1303 (0.08%)  1
Heart Failure Decompensation   2/1303 (0.15%)  2
Premature Ventricular Contractions (PVCs)   1/1303 (0.08%)  1
Impedance Related, Atrial Lead   1/1303 (0.08%)  1
Lead Dislodgment, Atrial Lead   6/1303 (0.46%)  6
Sensing Related, Atrial Lead   1/1303 (0.08%)  1
Threshold Related, Atrial Lead   2/1303 (0.15%)  2
Impedance Related, Right Ventricular   3/1303 (0.23%)  3
Inappropriate Tachy Therapy, Right Ventricular   3/1303 (0.23%)  3
Sensing Related, Right Ventricular   1/1303 (0.08%)  1
Threshold Related, Right Ventricular   5/1303 (0.38%)  5
Injury, poisoning and procedural complications   
Pneumothorax   1/1303 (0.08%)  1
Infection, Atrial Lead   1/1303 (0.08%)  1
Infection, Right Ventricular   1/1303 (0.08%)  1
Pneumothorax, Right Ventricular   1/1303 (0.08%)  1
Product Issues   
Pulse Generator Possible Malfunction   2/1303 (0.15%)  2
Surgical and medical procedures   
Cardiac Vessel Dissection   1/1303 (0.08%)  1
Lead Revision for no heart failure improvement, Left Ventricular   1/1303 (0.08%)  1
Pulse Generator Related  [1]  1/1303 (0.08%)  1
Erosion/Migration   9/1303 (0.69%)  10
Inability to provide therapy, pulse generator   5/1303 (0.38%)  5
Infection, Procedure related   10/1303 (0.77%)  10
Cardiac Perforation, Right Ventricular   1/1303 (0.08%)  1
Lead Dislodgment, Right Ventricular   5/1303 (0.38%)  5
Indicates events were collected by systematic assessment
[1]
Lead to device connection re-evaluated
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Implants
Affected / at Risk (%) # Events
Total   131/1303 (10.05%)    
Cardiac disorders   
Extracardiac Stimulation, Left Ventricular   77/1303 (5.91%)  88
Threshold Related, Left Ventricular   26/1303 (2.00%)  33
Inappropriate Tachy Therapy, Pulse Generator   28/1303 (2.15%)  36
Indicates events were collected by systematic assessment
Early termination was granted based on study results. The study was one-armed observational. The expected performance / safety of left ventricular leads has been established; permitting comparison to a pre-defined performance standard.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trial Management - cRM franchise
Organization: Boston Scientific
Phone: 1-800-227-3422
EMail: elaine.larson@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00955708    
Other Study ID Numbers: LSR of ACUITY Spiral
First Submitted: August 4, 2009
First Posted: August 10, 2009
Results First Submitted: July 10, 2018
Results First Posted: May 2, 2019
Last Update Posted: May 2, 2019