Attain Performa(TM) Quadripolar Lead Study

Study Overview
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Brief Summary
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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.

Official Title
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Attain Performa(TM) Quadripolar Lead Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines) Patient (or legally authorized representative) has signed and dated the study-specific Consent Form Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law Patient is expected to remain available for follow-up visits Patient understands the study and agrees to comply with study protocol Exclusion Criteria: Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study) Patient is contraindicated for < 1 mg dexamethasone acetate Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager) Patient has a life expectancy less than 180 days Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included Patient is unable to tolerate an urgent thoracotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attain Performa LV Lead (Models 4298, 4398, 4598)<br>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)<br>* Implant and follow-up of study lead, separate analysis for each lead model<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead Complication-free Rate at 6 Months | 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. | Implant to 6 months post-implant | 
| LV Pacing Capture Thresholds Per Attain Performa Lead Model |  | 6 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | 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. | 6 months post-implant | 
| Percentage of Subjects With Successful Implant Per Attain Performa Lead Model |  | Implant up to 1-month post implant | 
| Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model |  | Implant up to 1-month post implant | 
| Pacing Capture Thresholds at the Final Programmed Pacing Polarity |  | 6 months post-implant | 
| Implant Related Times Per Attain Performa Lead Model |  | Implant up to 1-month post implant | 
| Pacing Impedance at the Final Programmed Pacing Polarity | 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). | 6 month post-implant | 
| Complication Rate for Individual Attain Performa Lead Related Events |  | 6 month post-Implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead