Heart Failure
Conditions
Interventions
None listed
Sponsors
Medtronic Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is at least 20 years of age or older. 2. Subject will be implanted with Medtronic CRT device and Medtronic left-heart lead. The implant procedure may include upgrades to CRT from IPG or ICD. 3. Subject satisfies indications for Japanese CRT implantation.
Exclusion criteria
Exclusion criteria: 1. Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment. 2. Subject has existing CRT system implanted or was previously implanted with a CRT system. 3. Subject who will undergo an implant of either Medtronic Model 5071 Sutureless Myocardial Pacing Lead, Model 4968 CapSure Epi bipolar Epicardial Pacing Lead, or Model 4965 Epicardial Pacing Lead used as left-heart lead.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the implant success rate for the Attain left-heart leads. 2. To assess Attain left-heart lead related complication rate through three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess left-heart pacing threshold measured by left ventricular capture management (LVCM) and manual left ventricular capture threshold test at three month visit. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Yoshimura
Medtronic Japan Co., Ltd. CRHF Clinical
Outcome results
None listed