Attain Stability™ Quad Clinical Study
|ClinicalTrials.gov Identifier: NCT03099655|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: Attain Stability Quad Left Ventricular Pacing Lead|
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints.
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||471 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV lead. This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead (Model 20066/4796) (available outside of the United States).|
|Masking:||None (Open Label)|
|Official Title:||Attain Stability™ Quad Clinical Study|
|Actual Study Start Date :||July 7, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Attain Stability Quad Lead
Attain Stability Quad Lead (Model 4798) - Single arm study.
Device: Attain Stability Quad Left Ventricular Pacing Lead
Other Name: 4798 Lead
- Lead complication-free rate at 6 months [ Time Frame: Implant to 6 months post-implant ]Subjects free of Model 4798 lead-related complications at 6 months post-implant
- Proportion of subjects with at least one vector having PCT ≤2.5 V at 0.5 ms pulse width and absence of Phrenic Nerve Stimulation (PNS) [ Time Frame: Implant to 6 months post-implant ]The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V.
- Proportion of subjects with at least one extra vector having PCT ≤ 4.0V at 0.5 ms pulse width and absence of Phrenic Nerve Stimulation (PNS) [ Time Frame: Implant to 6 months post-implant ]The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy.
- Implant Success [ Time Frame: Intraoperative ]Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
- Implant Duration [ Time Frame: Intraoperative ]Summary statistics including mean and standard deviation will be obtained for implant duration (minutes) for each successful implant procedure.
- LV Pacing Capture Threshold (PCT) at 6 months [ Time Frame: Implant to 6 months post-implant ]Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject
- LV Impedance at 6 months [ Time Frame: Implant to 6 months ]Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject
- Post Implant lead failure rate [ Time Frame: Implant to 6 months ]Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099655
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