21 and older, any sex, with Sudden Cardiac Death. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All-Cause ShockPrimary· 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.
Group
Value
95% CI
ATP and Shock
129
Shock Only
178
All-Cause Shock or Death From Any CauseSecondary· 5 years
incidence of all-cause shocks or death from any cause
Group
Value
95% CI
ATP and Shock
297
Shock Only
322
Appropriate ShockSecondary· 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.
Group
Value
95% CI
ATP and Shock
96
Shock Only
132
Inappropriate ShockSecondary· 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.
Group
Value
95% CI
ATP and Shock
40
Shock Only
62
All Cause MortalitySecondary· 5 years
incidents of all cause mortality
Group
Value
95% CI
ATP and Shock
196
Shock Only
174
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Event data was collected from time of enrollment through a common end date and a median follow-up time of 40 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ATP and Shock
Serious: 633/1302 (49%)
Deaths: 196/1302
Shock Only
Serious: 618/1293 (48%)
Deaths: 175/1293
Serious adverse events (139 terms)
Reaction
System
ATP and Shock
Shock Only
Multiple heart failure symptoms
Cardiac disorders
—
—
Pulmonary
Respiratory, thoracic and mediastinal disorders
—
—
Gastrointestinal
Gastrointestinal disorders
—
—
Atrial Fibrillation (AF)
Cardiac disorders
—
—
Heart failure symptoms - Unspecified
Cardiac disorders
—
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Ventricular Tachycardia (VT)/Monomorphic VT
Cardiac disorders
—
—
Dyspnea - Heart failure
Cardiac disorders
—
—
Renal
Renal and urinary disorders
—
—
Systemic infection
Infections and infestations
—
—
Musculoskeletal
Musculoskeletal and connective tissue disorders
—
—
Death
General disorders
—
—
Myocardial infarction
Vascular disorders
—
—
Chest pain - Other
General disorders
—
—
Ventricular Fibrillation (VF)
Cardiac disorders
—
—
Hematological
Blood and lymphatic system disorders
—
—
Genitourinary
Renal and urinary disorders
—
—
Coronary Artery Disease
Vascular disorders
—
—
Neurological
Nervous system disorders
—
—
Cardiac arrest
Cardiac disorders
—
—
Cerebrovascular Accident (CVA) - unspecifed
Vascular disorders
—
—
Syncope
General disorders
—
—
Chest pain - Ischemic
Vascular disorders
—
—
Inappropriate Tachy Therapy - SVT - PG System Therapy
Product Issues
—
—
Cardiogenic shock
Cardiac disorders
—
—
Other adverse events (111 terms — click to expand)
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07372196 — Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
· NA
· recruiting
NCT06964464 — Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardio
· Phase 4
· recruiting
NCT06546137 — National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Un
· recruiting
NCT06771700 — S-ICD Implantation: US Based Pilot Study
· NA
· recruiting
NCT06954103 — Mechanisms And Prognosis of Stroke-Heart Syndrome
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 22 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02923726.