IDE-ALERTS Continued Access Study : ALERTS Continued Access Study- IDE G060259 Supplement
This Continued Access IDE Study is a prospective, non-randomized, multi-center (up to 25 sites) study designed to provide performance assessment of a refined Guardian implantable medical device (AMSG3-E) through controlled access of a replacement Guardian System to a subset of former ALERTS patients while waiting for FDA approval of the AMSG3-E. The AMSG3-E contains a drop-in replacement battery designed to extend the life of the implant to potentially exceed the previous 3-years implant life. Eligible patients will include those that exited the ALERTS study and chose to leave the device and/or lead in place. Eligible patients must also continue to meet ALERTS inclusion criteria and not have developed any exclusion criteria since exiting the ALERTS study..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 03. Juni Zur Gesamtaufnahme - year:2022 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 20, 2020, Last downloaded: ClinicalTrials.gov processed this data on June 07, 2022, Last updated: June 08, 2022 |
|---|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG003336689 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG003336689 | ||
| 003 | DE-627 | ||
| 005 | 20230425195212.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210408s2022 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG003336689 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT04316481 | ||
| 035 | |a (UBBS_Klinische_Studien)WRB 1281733 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a IDE-ALERTS Continued Access Study |b ALERTS Continued Access Study- IDE G060259 Supplement |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 20, 2020, Last downloaded: ClinicalTrials.gov processed this data on June 07, 2022, Last updated: June 08, 2022 | ||
| 520 | |a This Continued Access IDE Study is a prospective, non-randomized, multi-center (up to 25 sites) study designed to provide performance assessment of a refined Guardian implantable medical device (AMSG3-E) through controlled access of a replacement Guardian System to a subset of former ALERTS patients while waiting for FDA approval of the AMSG3-E. The AMSG3-E contains a drop-in replacement battery designed to extend the life of the implant to potentially exceed the previous 3-years implant life. Eligible patients will include those that exited the ALERTS study and chose to leave the device and/or lead in place. Eligible patients must also continue to meet ALERTS inclusion criteria and not have developed any exclusion criteria since exiting the ALERTS study. | ||
| 650 | 2 | |a Acute Coronary Syndrome | |
| 650 | 4 | |a Medical Condition: Acute Coronary Syndrome | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 03. Juni |
| 773 | 1 | 8 | |g year:2022 |g day:03 |g month:06 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04316481 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2022 |b 03 |c 06 | ||