Eligibility, any sex, with Primary Prevention of Sudden Cardiac Arrest or Secondary Prevention of Sudden Cardiac Arrest. 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.
Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-yearsPrimary· 5 years
The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
Group
Value
95% CI
RELIANCE 4-SITE
98.9
98.5 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RELIANCE 4-SITE
Serious: 1017/1820 (56%)
Deaths: 327/1820
Serious adverse events (127 terms)
Reaction
System
RELIANCE 4-SITE
Gastrointestinal
Gastrointestinal disorders
—
Multiple Heart Failure Symptoms
Cardiac disorders
—
Pulmonary
Respiratory, thoracic and mediastinal disorders
—
Heart Failure Symptoms - Unspecified
Cardiac disorders
—
Dyspnea - Heart Failure
Cardiac disorders
—
Renal
Renal and urinary disorders
—
Atrial Fibrillation (AF)
Cardiac disorders
—
Musculoskeletal
Musculoskeletal and connective tissue disorders
—
System Infection
Infections and infestations
—
Physical Trauma
General disorders
—
Ventricular Tachycardia (VT)/Monomorphic VT
Cardiac disorders
—
Chest Pain - Other
General disorders
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Myocardial Infarction
Vascular disorders
—
Patient Condition - Cardiovascular - OTHER
Cardiac disorders
—
Neurological
Nervous system disorders
—
Cerebrovascular Accident (CVA)
Vascular disorders
—
Genitourinary
Renal and urinary disorders
—
Patient Condition - Non-Cardiovascular - OTHER
General disorders
—
Cardiac Arrest
Cardiac disorders
—
Hematological
Blood and lymphatic system disorders
—
Integumentary
Skin and subcutaneous tissue disorders
—
Peripheral Vascular Disease
Vascular disorders
—
Death
General disorders
—
Hypotension/Orthostatic Hypotension
Vascular disorders
—
Other adverse events (132 terms — click to expand)
Reaction
System
RELIANCE 4-SITE
Head, eyes, ears, nose, throat (HEENT)
General disorders
—
Gastrointestinal
Gastrointestinal disorders
—
Musculoskeletal
Musculoskeletal and connective tissue disorders
—
Pulmonary
Respiratory, thoracic and mediastinal disorders
—
Atrial Fibrillation (AF)
Cardiac disorders
—
Patient Condition - Non-Cardiovascular - OTHER
General disorders
—
Integumentary
Skin and subcutaneous tissue disorders
—
Physical Trauma
General disorders
—
Abnormal Laboratory Values
General disorders
—
Genitourinary
Renal and urinary disorders
—
Chest Pain - Other
General disorders
—
Post Surgical wound discomfort/bruising/swelling
Injury, poisoning and procedural complications
—
Multiple Heart Failure Symptoms
Cardiac disorders
—
Renal
Renal and urinary disorders
—
Ventricular Tachycardia (VT)/Monomorphic VT
Cardiac disorders
—
Hematoma - pocket (≤ 30 days post-implant)
Injury, poisoning and procedural complications
—
Neurological
Nervous system disorders
—
Hypotension/Orthostatic Hypotension
Vascular disorders
—
Dizziness
General disorders
—
Endocrine
Endocrine disorders
—
Nonsustained ventricular tachycardia (NSVT)
Cardiac disorders
—
Dyspnea - Heart Failure
Cardiac disorders
—
Inappropriate Tachy Therapy - SVT
Product Issues
—
Hypertension/Hypertensive Crisis
Vascular disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Peripheral edema - Heart Failure
Cardiac disorders
—
Fatigue/Weakness
General disorders
—
Heart Failure Symptoms - Unspecified
Cardiac disorders
—
Hematological
Blood and lymphatic system disorders
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT
· not yet recruiting
NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy
· NA
· not yet recruiting
NCT07276815 — OverStitch NXT Endoscopic Suture System
· NA
· not yet recruiting
NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
· NA
· not yet recruiting
NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
· NA
· not yet recruiting
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: 19 March 2021
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/NCT01596595.