Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00231426
Other study ID # CR-CA-031203-M
Secondary ID
Status Completed
Phase Phase 4
First received September 30, 2005
Last updated November 20, 2006
Start date June 2003
Est. completion date November 2005

Study information

Verified date November 2006
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices

- Patients who sign and date a Patient Informed Consent form prior to the implant visit

- Patients who remain in the clinical care of the enrolling physician in approved centers

- Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex

- Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV

Exclusion Criteria:

- Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies

- Patients who undergo lead repositioning

- Patients who are expected to receive a heart transplant during the duration of the study

- Patients who have or who are likely to receive a tricuspid valve prosthesis

- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study

- Patients who are younger than 18 years of age

- Patients who are pregnant or plan to become pregnant during the study

- Patients whose life expectancy is less than 12 months

- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
ICD


Locations

Country Name City State
United States LDS Hospital Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT02849769 - Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Completed NCT04025710 - Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep) N/A
Active, not recruiting NCT05621187 - Post Market Clinical Follow-up Study for the Pamira ICD Lead Family N/A
Not yet recruiting NCT06382207 - Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs N/A
Active, not recruiting NCT01526629 - Full Automaticity and Remote Follow-up N/A
Completed NCT03850327 - BIO|CONCEPT.BIOMONITOR III N/A
Recruiting NCT04905199 - Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Completed NCT03408951 - Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Not yet recruiting NCT06327425 - MCG for Localization of Tachyarrhythmia's Origin N/A
Recruiting NCT04863664 - Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) N/A
Not yet recruiting NCT05750108 - Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction N/A
Completed NCT02774616 - BIO|MASTER.Ilivia Family / Plexa N/A
Completed NCT02181686 - Iperia/Sentus QP Study N/A
Terminated NCT03451227 - Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures N/A
Completed NCT02933619 - ProMRI ICD/CRT-D Post Approval Study
Completed NCT00324662 - Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA) Phase 4
Completed NCT00170274 - APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias N/A
Completed NCT03891329 - Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead N/A
Completed NCT06323499 - Outcome of Induced Atypical Atrial Flutter