Device Replacement Clinical Trial
Official title:
Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry
This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.
Based on positive outcomes from numerous randomized, controlled trials, the implantable
defibrillators have been included in the current European Society of Cardiology (ESC) and
American College of Cardiology / American Heart Associations (ACC/AHA) guidelines as a
standard of care in selected patients, and thus ICD use is currently increasing worldwide.
In the years after initial implantation, device replacement may become necessary for battery
depletion or for upgrades to more complex multi-lead ICDs. The increase in generator or lead
advisories and recalls contributes further to those patients considered for replacement.
The determination of procedural adverse events is complex, and requires monitoring of both
short-term complications and long-term patient outcome.
Previous retrospective series have examined complications with ICD replacements. Moreover,
the more recent REPLACE registry prospectively collected 6-month complication rates in
patients undergoing pacemaker or ICD generator replacement at 72 private practice and
academic sites in United States. This study examined a broad range of major and minor
complications and found that ICD replacements were associated with a notable complication
risk, particularly when a transvenous lead addition or revision was required.
Previous retrospective series have examined complications with ICD implantation in the
Italian clinical practice, showing frequent interventions for system revision and
demonstrating an association between adverse events and the complexity of the implanted
device (i.e. Cardiac Resynchronization Therapy CRT-D versus single- or dual-chamber ICD).
Moreover, it was shown that device replacement procedures are associated with significantly
higher risk of infections.
Nonetheless, detailed data on the complications of ICD replacement in the current Italian
clinical practice are unavailable.
This information would be particularly important because ICD replacement-related events may
be associated not only with a worse clinical outcome, but also with incremental costs to the
healthcare system.
The analysis of adverse events would permit to study new preventative strategies with
significant clinical as well as financial benefits. Moreover, the quantification of the
complication rate after ICD replacement would permit to estimate the actual long-term cost
of ICD therapy, and to assess the impact of ICD longevity on the cost-effectiveness of the
therapy.
This study has been designed to prospectively estimate long term complication rates (at
12-months and 5-years) in patients undergoing ICD generator replacement. The study also
evaluates predictors of complications, patient's management before and during the
replacement procedure in clinical practice and the estimated costs related to the use of
health care resources.
All consecutive patients with standard indications to ICD generator replacement will be
enrolled In this study. The decision to perform the generator replacement or to upgrade an
existing device will be made according to the investigators' clinical assessment of their
patient. The study do not mandate specific surgical or implantation techniques such as
venous access, use of temporary pacemakers, or surgical site choices. Any commercially
available generator or lead can be included.
Patients will be followed for a 60-month period with periodical in-hospital visits or remote
ICD interrogations via remote patient monitoring (RPM) systems, according to the standard
hospital practice and the physician's discretion.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02323503 -
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
|
||
| Completed |
NCT00395447 -
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
|
Phase 4 |