Health Condition 1: null- Heart Failure
Conditions
Interventions
Intervention1: Model 4298, Model 4398, and Model 4598 LV leads will be evaluated in this
clinical study: This study will evaluate the safety and efficacy of the Medtronic Attain Performa Leads. Since
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In the US only, this is based on Class I and II indications for CRTD implant per HRS/ACC/AHA guidelines) 2. Patient (or legally authorized representative) has signed and dated the study specific Consent Form 3. Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law 4. Patient is expected to remain available for follow-up visits 5. Patient understands the study and agrees to comply with study protocol
Exclusion criteria
Exclusion criteria: 1. 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 2. Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) 3. Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study) 4. Patient is contraindicated for 1 mg dexamethasone acetate 5. Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Coenrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronicâ??s study manager) 6. Patient has a life expectancy less than 180 days 7. Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) 8. Patient is unable to tolerate an urgent thoracotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lead complication-free rate at 6 months 2. The lead will be considered effective if the proportion of subjects with a final programmed LV lead pacing polarity having a pacing capture threshold less than or equal to 2.5 V at 0.5ms pulse width at 6 months post-implant is greater than 80% Timepoint: 1. Lead complication-free rate at 6 months 2. The lead will be considered effective if the proportion of subjects with a final programmed LV lead pacing polarity having a pacing capture threshold less than or equal to 2.5 V at 0.5ms pulse width at 6 months post-implant is greater than 80% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate occurrence of PNS in all LV lead pacing polarities 2. Summarize implant success rates 3. Characterize system related complicationsTimepoint: 12 months | — |
Countries
Canada, India, Netherlands, South Africa, United States of America
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt Ltd
Outcome results
None listed