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Clinical Trial NCT04331249 (EVINCE) for Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication, Surgery--Complications is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Perioperative Management Evaluation in Patients With CIED (EVINCE) 500 Randomized Observational
Clinical Trial NCT04331249 (EVINCE) is an observational study for Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication, Surgery--Complications that is recruiting. It started on 27 November 2018 with plans to enroll 500 participants. Led by Klinikum-Fuerth, it is expected to complete by 31 December 2030. The latest data from ClinicalTrials.gov was last updated on 15 October 2024.
Brief Summary
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.
Study design: bi-center, non-randomi...
Show MoreDetailed Description
Background: The number of worldwide implanted cardiac electronic devices (CIED) is increasing continuously. On the other hand, the number of (more and more complex) surgical and catheter based interventions in this population is increasing as well. Recommendations for peri-operative management are often based on older data from case reports and small collectives. Data especially in particular subpopulations is limite...Show More
Official Title
Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
Conditions
Cardiac Pacemaker MalfunctionICD MalfunctionCardiac Pacemaker Electrical InterferenceAnesthesia ComplicationSurgery--ComplicationsOther Study IDs
- EVINCE
- EVINCE_KHF
NCT ID Number
Start Date (Actual)
2018-11-27
Last Update Posted
2024-10-15
Completion Date (Estimated)
2030-12-31
Enrollment (Estimated)
500
Study Type
Observational
Status
Recruiting
Keywords
pacemaker
implanted cardioverter defibrillator
cardiac resynchronisation therapy
management, peri-operative
implanted cardioverter defibrillator
cardiac resynchronisation therapy
management, peri-operative
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | surgery or catheter based cardiac procedure (catheter ablation) patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
surgery or catheter-based procedure related (S)ADE | any (S)ADE related to the surgical or catheter-based procedure | 1 month post-procedural |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
device: post-procedural pacing threshold increase | post-procedural pacing threshold increase \> 50% compared with the pre-procedural threshold (given a safety margin of 100%) | 1 month post-procedural |
device: post-procedural sensing decrease | post-procedural sensing decrease by \> 50% compared with the pre-procedural sensing | 1 month post-procedural |
device: post-procedural lead impedance | post-procedural lead impedance is different by \> 25% compared with the pre-procedural impedance | 1 month post-procedural |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- implanted CIED (e.g. pacemaker, ICD, CRT),
- performed (non-CIED related) surgical or catheter-based procedure,
- data from peri-procedural CIED interrogation available
- age >18 years
- no implanted CIED,
- no data from any peri-interventional CIED interrogation available
Klinikum-FuerthKlinikum NürnbergStudy Central Contact
Contact: Dirk Bastian, MD, +49 (0)911 7580 1101, [email protected]
Contact: Laura Vitali-Serdoz, MD, +49 (0)911 7580 1101, [email protected]
2 Study Locations in 1 Countries
Bavaria
Klinikum Fuerth, Fürth, Bavaria, 90766, Germany
Dirk Bastian, MD, Contact, +49 (0)911 7580 1101, [email protected]
Laura Vitali-Serdoz, MD, Contact, +49 (0)911 7580 1101, [email protected]
Recruiting
Klinikum Nuernberg, Nuremberg, Bavaria, 90471, Germany
Timur Mamedov, Contact, [email protected]
Recruiting