The 4-SITE Field Following Study (4-SITE FF)

NCT00920452 | Completed

• 1 other identifier: 4-SITE FF 0209
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads. Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study. Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.

Conditions

ICD and CRT-D Indicated Patients

Keywords

implantable cardioverter defibrillator (ICD); defibrillation leads, cardiac resynchronization therapy (CRT)

Outcome Measures

Primary Outcomes (5)

• Appropriate Detection of induced VT

  Induced mean VT/VF detection time \< 4.5 seconds

  At Implant or during VT/VF testing up to one month after implant

• Appropriate induced VT/VF Shock Conversion

  Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher

  At Implant or during testing within one month after implant

• Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads

  Mean pacing threshold post implant ≤ 1.5V

  entire duration of the study

• Appropriate Lead Impedances as a measure of lead integrity over 12 month time

  * Shocking lead impedance should be within the range of 20 and 80 OHM * Pace /sense lead impedance within 200 and 2000 OHM

  entire study duration

• Appropriate sensing and absence of artefacts

  Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU

  entire duration of study

Eligibility Criteria

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

Study Population

Study Population: Patients should be selected from the investigator's general population indicated for an ICD or CRT-D Implantation. The investigator has the responsibility of screening all potential patients and selecting those who meet study eligibility criteria.

You may qualify if:

• Study Specific:
• ICD / CRT-D Indication according to normal clinical practice
• Patients receiving:
• a single or dual chamber 4-SITE compatible ICD
• or a 4-SITE compatible CRT-D
• one of the RELIANCE 4-SITE defibrillation leads
• Patients currently implanted with a pacemaker
• upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
• one of the RELIANCE 4-SITE defibrillation leads
• General:
• Willing and capable of providing informed consent for
• undergoing a 4-SITE system implant,
• participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
• Geographically stable patients who are available for follow-up at a study centre
• Age 18 or above, or of legal age to give informed consent specific to national law

You may not qualify if:

• Study Specific:
• ICD and CRT-D Patients scheduled for a device replacement
• CRM Patients who have or who would need an lead adaptor
• All patients who have an active or non-active defibrillation lead other than 4-SITE
• General:
• Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
• Patients who were in NYHA Class IV during the last 3 month
• Patients with pre-existing diseases, which may confound study results
• Patients currently requiring dialysis,
• Cancer patients
• Patients with drug and/or alcohol abuse history
• Life expectancy \< 12 months (or expected heart transplant within 12 months)
• Patients on a Heart Transplant List
• Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
• Enrolled in any other concurrent study

Sponsors & Collaborators

• Guidant Corporation: lead

Study Sites (1)

Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, D - 32545, Germany

Location

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2010-11

Locations

DE (1)