UMIN ID: UMIN000001458
Registered date:28/10/2008
Comparison of Automatic and Manual Threshold Testing
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patient implanted with cardiac pacemaker |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 500 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Time to complete device follow-up. |
|---|---|
| Secondary Outcome | Measured pacing threshold. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patient who is not abpe to program device automatic features (i.e., ACM, VCM or Sensing Assurance). 2) Patient who is not able to visit clinic according to scheduled follow-up. |
Related Information
| Primary Sponsor | Medtronic Japan Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Medtronic Japan Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Comodio Shiodome 5F, 2-14-1 Higashi-Simbashi, Minato-ku, Tokyo Japan |
| Telephone | 03-6430-7023 |
| Affiliation | Medtronic Japan Co., Ltd. CRDM Clinical |
| scientific contact | |
| Name | Soichi Tsunoda |
| Address | Comodio Shiodome 5F, 2-14-1 Higashi-Simbashi, Minato-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Medtronic Japan Co., Ltd. CRDM Clinical |