N/A
Completed N=1,125
Attain Performa(TM) Quadripolar Lead Study
Source: ClinicalTrials.gov NCT01751022 ↗Enrolled (actual)
1,125
Serious AEs
41.7%
Results posted
Dec 2016
Primary outcomePrimary: Lead Complication-free Rate at 6 Months — 96.04; 98.75; 96.21 Survival Probability (%)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lead Complication-free Rate at 6 Months |
96.04; 98.75; 96.21 | — |
| PRIMARY LV Pacing Capture Thresholds Per Attain Performa Lead Model |
93.92; 96.24; 95.86 | — |
| SECONDARY Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities |
42.03; 44.19; 44.57; 38.48; 40.45; 35.58 | — |
| SECONDARY Percentage of Subjects With Successful Implant Per Attain Performa Lead Model |
97.60; 97.55; 98.00 | — |
| SECONDARY Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model |
98.00; 98.47; 98.67; 0.20; 0.31; 0.33 | — |
| SECONDARY Pacing Capture Thresholds at the Final Programmed Pacing Polarity |
1.06; 1.15; 1.10 | — |
| SECONDARY Implant Related Times Per Attain Performa Lead Model |
6.3; 8.45; 6.87; 21.7; 23.00; 18.77 | — |
| SECONDARY Pacing Impedance at the Final Programmed Pacing Polarity |
460.56; 466.24; 496.45; 780.49; 802.52; 826.69 | — |
| SECONDARY Complication Rate for Individual Attain Performa Lead Related Events |
3.70; 1.58; 3.74 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01751022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.