Trial Outcomes & Findings for REPLACE: Implantable Cardiac Pulse Generator Replacement Registry (NCT NCT00395447)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

1744 participants

Primary outcome timeframe

6 months

Results posted on

2015-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	'Straight-forward' Device Replacement Cohort for patients undergoing a straight-forward device replacement without any planned system modification	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.
Overall Study STARTED	1031	713
Overall Study COMPLETED	910	602
Overall Study NOT COMPLETED	121	111

Reasons for withdrawal

Reasons for withdrawal
Measure	'Straight-forward' Device Replacement Cohort for patients undergoing a straight-forward device replacement without any planned system modification	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.
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

REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	'Straight-forward' Device Replacement n=1031 Participants Cohort for patients undergoing a straight-forward device replacement without any planned system modification	Replacement With Planned System Modification n=713 Participants 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.	Total n=1744 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 14 • n=5 Participants	70 years STANDARD_DEVIATION 13 • n=7 Participants	70 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	389 Participants n=5 Participants	172 Participants n=7 Participants	561 Participants n=5 Participants
Sex: Female, Male Male	642 Participants n=5 Participants	541 Participants n=7 Participants	1183 Participants n=5 Participants
Region of Enrollment United States	1031 participants n=5 Participants	713 participants n=7 Participants	1744 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	'Straight-forward' Device Replacement n=1031 Participants Cohort for patients undergoing a straight-forward device replacement without any planned system modification	Replacement With Planned System Modification n=713 Participants 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.
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 (%) Interval 9.9 to 12.8	20.9 Percentage of participants (%) Interval 18.0 to 24.1

Adverse Events

'Straight-forward' Device Replacement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Replacement With Planned System Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Crystal Miller, Clinical Studies Engineer

BIOTRONIK, Inc

Phone: 503-451-8051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information obtained from BIOTRONIK or PharmaLink concerning the research ideas used in this study and all information obtained under or concerning this study is considered BIOTRONIK property. Investigator will maintain such information in confidence and not release it to anyone without written consent from BIOTRONIK or prior public disclosure, with the exception of information required by law or regulations to be disclosed to the reviewing IRB, the patient, or the FDA.
Publication restrictions are in place

Restriction type: OTHER