Trial · NCT02235545

Optisure Lead Post Approval Study

NCT02235545, Terminated, Abbott Medical Devices; results first posted 2025-07-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optisure Lead Post Approval Study. Trials, record NCT02235545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02235545

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Optisure Lead Post Approval Study
NCT number: NCT02235545
Status: Terminated
Enrollment: 1,735 participants, actual
Lead sponsor: Abbott Medical Devices
Conditions: Heart Failure, Tachycardia, Ventricular
Interventions: St. Jude Medical Optisure Lead
First posted: 2014-09-10
Last updated: 2025-07-30
Results first posted: 2025-07-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.	5 years	Freedom from right ventricle (RV) lead related complications within 30 days of implant at 5 years follow-up Due to early termination of study, the sample size at 5 years follow-up was insufficient to perform the pre-specified primary endpoint analysis. The endpoint was evaluated using the Kaplan-Meier method however the hypothesis test was not performed due to insufficient sample size. The percentage freedom from RV lead related complications was summarized through 5-years from attempted RV lead implant. For subjects who experienced RV lead related complication, the time to event will be calculated from the attempted implant to the date that the first event occurred. For subjects that did not experience the complication, the time to event was censored at their last known event-free time point.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.	5 years	Subjects with an attempted implant.	% pts free from RV related complications	NUMBER

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.	St. Jude Medical Optisure Lead		96.3	95% Confidence Interval 94.0 to 97.8	% pts free from RV related complications

Source ClinicalTrials.gov

Participant flow17

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	St. Jude Medical Optisure Lead	1,735
Overall Study	Withdrawal Before 12 Month (12M) Follow-up (FU) Visit	St. Jude Medical Optisure Lead	102
Overall Study	Deaths Before 12M FU Visit	St. Jude Medical Optisure Lead	101
Overall Study	Completed 12M FU Visit	St. Jude Medical Optisure Lead	1,389
Overall Study	Withdrawals Before 24M FU Visit	St. Jude Medical Optisure Lead	107
Overall Study	Deaths Before 24M FU Visit	St. Jude Medical Optisure Lead	89
Overall Study	Completed 24M FU Visit	St. Jude Medical Optisure Lead	1,203
Overall Study	Withdrawals Before 36M FU Visit	St. Jude Medical Optisure Lead	93
Overall Study	Deaths Before 36M FU Visit	St. Jude Medical Optisure Lead	70
Overall Study	Completed 36M FU Visit	St. Jude Medical Optisure Lead	1,023

1 to 10 of 17Source ClinicalTrials.gov

See all 17 participant flow

Adverse events114

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abnormal Lead Defibrillation Impedance <=20 ohms or >=100 ohms	Product Issues	Right Ventricle Lead-Related Complications	1	1,735	1
other	Abnormal Lead Defibrillation Impedance <=20 ohms or >=100 ohms	Product Issues	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	1	1,735	1
other	Abnormal Lead Pacing Impedance <=200 ohms or >=200 ohms	Product Issues	Right Ventricle Lead-Related Complications	1	1,735	1
other	Abnormal Lead Pacing Impedance <=200 ohms or >=200 ohms	Product Issues	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	1	1,735	2
other	Elevated Pacing Thresholds	Product Issues	Right Ventricle Lead-Related Complications	9	1,735	10
other	Elevated Pacing Thresholds	Product Issues	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	13	1,735	13
other	Inappropriate Delivery of Therapy	Product Issues	Right Ventricle Lead-Related Complications	5	1,735	5
other	Inappropriate Delivery of Therapy	Product Issues	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	28	1,735	32
other	Lead Dislodgement or Migration	Product Issues	Right Ventricle Lead-Related Complications	1	1,735	1
other	Lead Dislodgement or Migration	Product Issues	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	3	1,735	3

1 to 10 of 114Source ClinicalTrials.gov

See all 114 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Right Ventricle Lead-Related Complications	323	1,735
Total, all-cause mortality	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	323	1,735
Total, other adverse events	Right Ventricle Lead-Related Complications	58	1,735
Total, other adverse events	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	137	1,735
Total, serious adverse events	Right Ventricle Lead-Related Complications	58	1,735
Total, serious adverse events	Summary of System and/or Procedure Related Complications Not Related to the RV Lead.	134	1,735

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Right Ventricle Lead-Related Complications vs Summary of System and/or Procedure Related Complications Not Related to the RV Lead.: deaths from any cause	Trial comparisons
Right Ventricle Lead-Related Complications vs Summary of System and/or Procedure Related Complications Not Related to the RV Lead.: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02235545

GET https://conductscience.org/api/trials/v1/NCT02235545/events?page=2

API reference For AI assistants