CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,744 enrolled
Drug / intervention
Straight-forward Device Replacement +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00395447
NCT00395447N/ACompleted
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Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade

Biotronik, Inc.·observational·Posted Nov 3, 2006·Updated Apr 14, 2015

In Brief

An observational study evaluating Straight-forward Device Replacement and Device Replacement with Upgrade for Device Replacement and 4 related conditions. Completed, enrolled 1,744 participants across 71 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDevice Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade, Postoperative Complications
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 2006
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.7 years ago

Interventions

Straight-forward Device Replacementprocedure

Device Replacement with Upgradeprocedure