Trial · NCT00800384

Shockless Implant Evaluation

NCT00800384, Not applicable, Completed, Boston Scientific Corporation; results first posted 2015-12-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Shockless Implant Evaluation. Trials, record NCT00800384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00800384

On this page

Trial

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

Title: Shockless Implant Evaluation
NCT number: NCT00800384
Status: Completed
Phases: Not applicable
Enrollment: 2,500 participants, actual
Lead sponsor: Boston Scientific Corporation
Conditions: Ventricular Fibrillation, Ventricular Tachycardia
Interventions: Implantable defibrillator
First posted: 2008-12-02
Last updated: 2018-03-30
Results first posted: 2015-12-22

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	Mean follow-up of 3.1 years	The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Secondary	Perioperative Complication Rate	30 days	A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	Mean follow-up of 3.1 years	All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.	participants	NUMBER
SECONDARY	Perioperative Complication Rate	30 days	Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.	participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	ICD Implant Without Defibrillation Testing	90	participants
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	ICD Implant With Defibrillation Testing	104	participants
Perioperative Complication Rate	ICD Implant Without Defibrillation Testing	69	participants
Perioperative Complication Rate	ICD Implant With Defibrillation Testing	81	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ICD Implant Without Defibrillation Testing	1,247
Overall Study	STARTED	ICD Implant With Defibrillation Testing	1,253
Overall Study	COMPLETED	ICD Implant Without Defibrillation Testing	1,206
Overall Study	COMPLETED	ICD Implant With Defibrillation Testing	1,210
Overall Study	NOT COMPLETED	ICD Implant Without Defibrillation Testing	41
Overall Study	NOT COMPLETED	ICD Implant With Defibrillation Testing	43

Source ClinicalTrials.gov

Adverse events668

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	PG System	Cardiac disorders	ICD Implant Without Defibrillation Testing	1	1,247	1
other	PG System	Cardiac disorders	ICD Implant With Defibrillation Testing	0	1,253	0
other	Oversensing - RA	Cardiac disorders	ICD Implant Without Defibrillation Testing	1	1,247	1
other	Oversensing - RA	Cardiac disorders	ICD Implant With Defibrillation Testing	0	1,253	0
other	Other - PG system	Cardiac disorders	ICD Implant Without Defibrillation Testing	3	1,247	3
other	Other - PG system	Cardiac disorders	ICD Implant With Defibrillation Testing	0	1,253	0
other	Unable to convert - Defibrillation	Cardiac disorders	ICD Implant Without Defibrillation Testing	1	1,247	1
other	Unable to convert - Defibrillation	Cardiac disorders	ICD Implant With Defibrillation Testing	2	1,253	2
other	Elevated DFT - Defibrillation	Cardiac disorders	ICD Implant Without Defibrillation Testing	0	1,247	0
other	Elevated DFT - Defibrillation	Cardiac disorders	ICD Implant With Defibrillation Testing	3	1,253	3

1 to 10 of 668Source ClinicalTrials.gov

See all 668 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ICD Implant Without Defibrillation Testing
Total, all-cause mortality	ICD Implant With Defibrillation Testing
Total, other adverse events	ICD Implant Without Defibrillation Testing	625	1,247
Total, other adverse events	ICD Implant With Defibrillation Testing	632	1,253
Total, serious adverse events	ICD Implant Without Defibrillation Testing	776	1,247
Total, serious adverse events	ICD Implant With Defibrillation Testing	790	1,253

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25715991	DERIVED	PubMed
26569461	DERIVED	PubMed
29157723	DERIVED	PubMed

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 comparisons3

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

Comparison	Source
ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: Perioperative Complication Rate	Trial comparisons
ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	Trial comparisons
ICD Implant Without Defibrillation Testing vs ICD Implant With Defibrillation Testing: 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/NCT00800384

GET https://conductscience.org/api/trials/v1/NCT00800384/events?page=2

API reference For AI assistants