Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.
The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD implantation only | Active Comparator | ICD Implantation without testing of defibrillation threshold testing |
|
| Modified upper limit of vulnerability testing | Active Comparator | Modified testing of "upper limit of vulnerability" |
|
| VF-Induction | Active Comparator | traditional VF-induction with T-Wave shock |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD Implantation without DFT testing | Device | Implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of different ICD-implantation strategies on release of high sensitivity Troponin | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of different ICD-implantation strategies on BNP release | 6 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität München | München | Bavaria | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26208329 | Derived | Semmler V, Biermann J, Haller B, Jilek C, Sarafoff N, Lennerz C, Vrazic H, Zrenner B, Asbach S, Kolb C. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One. 2015 Jul 24;10(7):e0131570. doi: 10.1371/journal.pone.0131570. eCollection 2015. |
| Label | URL |
|---|---|
| Publication Trop-Shock-Study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Upper limit of vulnerability testing |
| Device |
Upper limit of vulnerability testing |
|
| T-wave shock with induction of ventricular fibrillation | Device | Traditional safety margin testing for defibrillation threshold |
|