Trial · NCT02923726
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
NCT02923726, Not applicable, Completed, Boston Scientific Corporation; results first posted 2024-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP. Trials, record NCT02923726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02923726
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
- NCT number
- NCT02923726
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,692 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Sudden Cardiac Death
- Interventions
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- First posted
- 2016-10-05
- Last updated
- 2024-10-22
- Results first posted
- 2024-10-22
- Limitations and caveats
COVID-19 led to an increase in missed visits, late visits, withdrawals and several site personnel changes.~Additional ATP programming options were not evaluated, only the effect of a single ATP burst of 8 pulses at 88% cycle length.~The differential delay to shock between arms due to ATP (\~3 seconds) may have led to more shocks in the Shock Only arm.~The utility of ATP in other primary prevention indications was not assessed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-Cause Shock | 5 years | The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint. |
| Secondary | All-Cause Shock or Death From Any Cause | 5 years | incidence of all-cause shocks or death from any cause |
| Secondary | Appropriate Shock | 5 years | incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint. |
| Secondary | Inappropriate Shock | 5 years | incidence of first inappropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Inappropriate shocks contributed to the evaluation of this endpoint. |
| Secondary | All Cause Mortality | 5 years | incidents of all cause mortality |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-Cause Shock | 5 years | All randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-Cause Shock or Death From Any Cause | 5 years | All randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Appropriate Shock | 5 years | Randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Inappropriate Shock | 5 years | All randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cause Mortality | 5 years | All randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-Cause Shock | ATP and Shock | 129 | Participants | ||
| All-Cause Shock | Shock Only | 178 | Participants | ||
| All-Cause Shock or Death From Any Cause | ATP and Shock | 297 | Participants | ||
| All-Cause Shock or Death From Any Cause | Shock Only | 322 | Participants | ||
| Appropriate Shock | ATP and Shock | 96 | Participants | ||
| Appropriate Shock | Shock Only | 132 | Participants | ||
| Inappropriate Shock | ATP and Shock | 40 | Participants | ||
| Inappropriate Shock | Shock Only | 62 | Participants | ||
| All Cause Mortality | ATP and Shock | 196 | Participants | ||
| All Cause Mortality | Shock Only | 174 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATP and Shock | 1,302 | |
| Overall Study | STARTED | Shock Only | 1,293 | |
| Overall Study | COMPLETED | ATP and Shock | 769 | |
| Overall Study | COMPLETED | Shock Only | 811 | |
| Overall Study | NOT COMPLETED | ATP and Shock | 533 | |
| Overall Study | NOT COMPLETED | Shock Only | 482 |
Source ClinicalTrials.gov
Adverse events500
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 | Oversensing - RA PG System | Product Issues | ATP and Shock | 2 | 1,302 | 2 |
| other | Oversensing - RA PG System | Product Issues | Shock Only | 1 | 1,293 | 1 |
| other | Undersensing - RA PG System | Product Issues | ATP and Shock | 1 | 1,302 | 1 |
| other | Undersensing - RA PG System | Product Issues | Shock Only | 0 | 1,293 | 0 |
| other | Oversensing - RV PG System | Product Issues | ATP and Shock | 1 | 1,302 | 1 |
| other | Oversensing - RV PG System | Product Issues | Shock Only | 0 | 1,293 | 0 |
| other | Impedance Out of Range - RV PG System | Product Issues | ATP and Shock | 1 | 1,302 | 1 |
| other | Impedance Out of Range - RV PG System | Product Issues | Shock Only | 0 | 1,293 | 0 |
| other | Oversensing - Defibrillation - PG System | Product Issues | ATP and Shock | 1 | 1,302 | 1 |
| other | Oversensing - Defibrillation - PG System | Product Issues | Shock Only | 0 | 1,293 | 0 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATP and Shock | 196 | 1,302 |
| Total, all-cause mortality | Shock Only | 175 | 1,293 |
| Total, other adverse events | ATP and Shock | 420 | 1,302 |
| Total, other adverse events | Shock Only | 448 | 1,293 |
| Total, serious adverse events | ATP and Shock | 633 | 1,302 |
| Total, serious adverse events | Shock Only | 618 | 1,293 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39361311 | DERIVED |
Source 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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ATP and Shock vs Shock Only: Appropriate Shock | Trial comparisons |
| ATP and Shock vs Shock Only: Inappropriate Shock | Trial comparisons |
| ATP and Shock vs Shock Only: All-Cause Shock | Trial comparisons |
| ATP and Shock vs Shock Only: All Cause Mortality | Trial comparisons |
| ATP and Shock vs Shock Only: All-Cause Shock or Death From Any Cause | Trial comparisons |
| ATP and Shock vs Shock Only: deaths from any cause | Trial comparisons |
| ATP and Shock vs Shock Only: 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.
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/NCT02923726
GET https://conductscience.org/api/trials/v1/NCT02923726/events?page=2