SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

NCT00940888 | Completed Results

• 1 other identifier: 60020938
• Study Type: observational
• Target: 1,701
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Conditions

Tachyarrhythmias; Sudden Cardiac Death; Heart Failure

Keywords

ICD; CRTD; Heart Failure; DF4

Outcome Measures

Primary Outcomes (2)

• Right Ventricle (RV) Bipolar Capture Thresholds

  5 years

• Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector

  5 years

Study Arms (1)

No treatment: ICD/CRTD-indicated

Device: SJ4 connector and RV high voltage SJ4 lead

Interventions

SJ4 connector and RV high voltage SJ4 lead DEVICE

Standard of care implantation of SJ4 device system

No treatment: ICD/CRTD-indicated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICD and CRTD indicated patients

You may qualify if:

• Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
• Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.

You may not qualify if:

• Be currently participating in a clinical investigation that includes an active treatment arm.
• Have a life expectancy of less than 6 months due to any condition.
• Be less than 18 years of age.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Tachycardia; Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Results Point of Contact

• Title: Grant Kim, Director Clinical Studies
• Organization: Saint Jude Medical

gkim@sjm.com

818-493-3147

Study Officials

• Bruce Wilkoff, MD

  The Clevleland Clinic Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2019
• Results First Posted: August 14, 2017

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)