Device Advisory, Device Replacement, Device Upgrade, Elective Replacement (ERI), Postoperative Complications
Conditions
Keywords
Cardiac Pacemaker, Defibrillator, Replacement, Upgrade
Brief summary
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.
Detailed description
Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade. Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement. Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known. To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement. This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure. Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.
Interventions
PROCEDUREStraight-forward Device Replacement
PROCEDUREDevice Replacement with Upgrade
Sponsors
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is able to give informed consent * Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer * Is clinically stable to tolerate the surgical procedure * Age 18 years or greater * Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit
Exclusion criteria
* Inability or unwillingness to give informed consent * Current system infection requiring generator explantation or lead extraction * Generator replacement requiring planned lead extraction * Participating in another cardiovascular investigational drug or device registry * A life expectancy of less than six months * Expected to receive a heart transplant within 6 months * All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) | 6 months | The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 'Straight-forward' Device Replacement Cohort for patients undergoing a straight-forward device replacement without any planned system modification | 1,031 |
| Replacement With Planned System Modification Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication. | 713 |
| Total | 1,744 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 37 | 32 |
| Overall Study | Lost to Follow-up | 52 | 43 |
| Overall Study | Withdrawal by Subject | 24 | 19 |
| Overall Study | Withdrawl - Other (not subject) | 8 | 17 |
Baseline characteristics
| Characteristic | 'Straight-forward' Device Replacement | Replacement With Planned System Modification | Total |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 14 | 70 years STANDARD_DEVIATION 13 | 70 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 1031 participants | 713 participants | 1744 participants |
| Sex: Female, Male Female | 389 Participants | 172 Participants | 561 Participants |
| Sex: Female, Male Male | 642 Participants | 541 Participants | 1183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,031 | 0 / 713 |
| serious Total, serious adverse events | 0 / 1,031 | 0 / 713 |
Outcome results
Primary
Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)
The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 'Straight-forward' Device Replacement | Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) | 10.8 Percentage of participants (%) |
| Replacement With Planned System Modification | Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) | 20.9 Percentage of participants (%) |