depressed LV function Heart failure
Conditions
Interventions
Implantation with an Attain Performa lead, Viva Quad CRT-D device, and
Medtronic RV lead with DF4 connector.
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient has an indication for a CRT-D device.
Exclusion criteria
Exclusion criteria: Patient has contraindications for standard transvenous cardiac pacing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Objective • Attain Performa Safety Objective: Lead complication-free rate at 6 months The Attain Performa lead will be considered safe if the proportion of subjects free of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the two-sided 95% lower confidence bound must be greater than 87%). Primary Efficacy Objectives The effectiveness of the lead will be evaluated based on two primary efficacy endpoints. The lead will be considered effective if both primary efficacy objectives are met simultaneously. The primary efficacy endpoints include pacing threshold assessments for the final programmed LV pacing configuration and for one additional programmable (non-programmed) pacing configuration while at least one of these two configurations must be a non-standard pacing vector. • Attain Performa lead Efficacy Objective #1 The Attain Performa lead will be considered effective if the proportion of subjects with final programmed pacing vector having pacing voltage threshold less than or equal to 2.5 V at 0.5ms pulse width at 6 months post-implant is greater than 80% (i.e., the two-sided 95% lower confidence bound must be greater than 80%). • Attain Performa lead Efficacy Objective #2 The Attain Performa lead will be considered effective if the proportion of subjects with a non-programmed pacing vector having a pacing voltage threshold less than or equal to 4.0 V at 0.5ms pulse width at 6 months post-implant is greater than 80% (i.e., the two-sided 95% lower confidence bound must be greater than 80%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives • Evaluate occurrences of PNS in all LV configurations, which will require: 1) Testing for presence of PNS at 8.0 V at 0.5ms performed at pre-hospital discharge, 3 months, 6 months, and 12 months post-implant for all LV lead vectors 2) Testing for PNS thresholds at 6 months and 12 months post-implant for all LV lead vectors where PNS is present at 8.0 V at 0.5ms 3) Assessment of all adverse events (AEs) for PNS that occur throughout study duration • Summarize implant success rates • Evaluate the following implant-related times: total implant, standard fluoroscopy, coronary sinus cannulation and successful lead placement • Evaluate the handling characteristics of the Attain Performa leads • Characterize the electrical performance of multiple pacing configurations (LV pacing capture threshold (PCT), sensing, impedance, and PNS) of the Attain Performa leads at pre-hospital discharge, 1 month, 3 months, 6, months, and every 6 months thereafter until study closure • Characterize all AEs • Characterize system related complications • Estimate individual failure rate through 6 months post-implant | — |
Countries
Netherlands
Outcome results
None listed