Attain Performa(TM) Quadripolar Lead Study
|Heart Failure||Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Attain Performa(TM) Quadripolar Lead Study|
- Lead Complication-free Rate at 6 Months [ Time Frame: Implant to 6 months post-implant ]
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:
- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).
- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.
The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
- LV Pacing Capture Thresholds Per Attain Performa Lead Model [ Time Frame: 6 months post-implant ]
- Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities [ Time Frame: 6 months post-implant ]Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.
- Percentage of Subjects With Successful Implant Per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ]
- Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ]
- Pacing Capture Thresholds at the Final Programmed Pacing Polarity [ Time Frame: 6 months post-implant ]
- Implant Related Times Per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ]
- Pacing Impedance at the Final Programmed Pacing Polarity [ Time Frame: 6 month post-implant ]
Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.
Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).
- Complication Rate for Individual Attain Performa Lead Related Events [ Time Frame: 6 month post-Implant ]
|Study Start Date:||December 2012|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Attain Performa LV Lead (Models 4298, 4398, 4598)
N/A: single arm study, separate analysis for each lead model (total of 3).
Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead, separate analysis for each lead model
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751022
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