Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
DeviceImplant and follow-up of study lead, separate analysis for each lead model
NCT Number: NCT01751022
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Randwick, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implant and follow-up of study lead, separate analysis for each lead model
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:
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.
Time frame: 6 months post-implant
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.
Time frame: Implant up to 1-month post implant
Time frame: Implant up to 1-month post implant
Time frame: 6 months post-implant
Time frame: Implant up to 1-month post implant
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).
Time frame: 6 month post-Implant
Medtronic Cardiac Rhythm and Heart Failure
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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