|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080006 S004/ PAS001 |
| Date Original Protocol Accepted |
03/31/2011
|
| Date Current Protocol Accepted |
06/29/2015
|
| Study Name |
Attain Ability Straight Model 4396
|
| Device Name |
MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective Cohort Study
|
| Study Population |
Inclusion Criteria
Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Subject is implanted with the Model 4396 LV lead connected and used for a pacing or sensing.
Subject within 30 days of implant
Exclusion Criteria
Subject who is, or will be inaccessible for follow-up at a site
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable
|
| Sample Size |
This study will consist of 1,016 patients implanted with Model 4396 lead enrolled from approximately 150 centers globally. The minimum Model 4396 enrollment of 1,016 leads results in approximately 600 leads followed for 5-years.
|
| Key Study Endpoints |
The primary objective of the PAS is to demonstrate that the Model 4396 lead-related complication-free rate is greater than 92.5% at five years post-implant.
|
| Follow-up Visits and Length of Follow-up |
Subjects in the PAS will be followed for a minimum of 5 years from their implant date.
Study follow-up visit schedules are based on a rolling visit window with the visit frequency: The required visit window is 210 days in length or approximately every 6 months from implant.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
368 leads in 366 patients
|
| Actual Number of Sites Enrolled |
65 sites
|
| Patient Follow-up Rate |
The overall follow-up rate was 87.56%
|
| Final Safety Findings |
As of the data cut-off date, there have been 45 Model 4396 LV lead
events reported to Medtronic, all of which have been reviewed by the CEC. Among the 45 CEC
adjudicated events, 18 (in 18 leads / 18 patients) were adjudicated as Model 4396 lead related
complications and 27 were classified as observations. The complication free rate at 60 months was
98.54%.
|
| Final Effect Findings |
There are 34 (9.6%) leads with elevated thresholds. There
were 2 leads with Elevated Impedance out of range at implant and at 60 month follow-up. There were
22 leads with sensing value out of range at 60 month follow-up.
|
| Study Strengths & Weaknesses |
The study results, along with the previous IDE results and approval,
demonstrate that the Model 4396 LV Lead is safe and effective for pacing and sensing the left ventricle
via a cardiac vein. Safety was demonstrated by the complication-free rate from Model 4396 lead-related
complications at five years (98.54%, Table 21). The results of the secondary objectives confirm that the
general electrical performance (e.g. threshold, sensing, impedance, etc.) of the Model 4396 LV lead is
stable over time and within expected values. The main weakness of the study was the low sample size due to low utilization of the Model 4396 LV Lead.
|
| Recommendations for Labeling Changes |
Yes
|
