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

Completed

• Conditions: ICD and CRT-D Indicated Patients

• Registration Number: NCT00920452
• Lead Sponsor: Guidant Corporation

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.

Detailed Description

The following devices will be used (all are CE-marked):

* TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD)

* Model Number: F103 (Quadripolar, VR);

* Model Number: F111 (Quadripolar, IS-1, DR)

* COGNIS 100 HE 4-SITE (CRT-D)

o Model Number: P108 (Quadripolar, IS-1, IS-1)

* RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2010-11
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appropriate induced VT/VF Shock Conversion	At Implant or during testing within one month after implant	Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher
Appropriate sensing and absence of artefacts	entire duration of study	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
Appropriate Detection of induced VT	At Implant or during VT/VF testing up to one month after implant	Induced mean VT/VF detection time \< 4.5 seconds
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads	entire duration of the study	Mean pacing threshold post implant ≤ 1.5V
Appropriate Lead Impedances as a measure of lead integrity over 12 month time	entire study duration	* Shocking lead impedance should be within the range of 20 and 80 OHM; * Pace /sense lead impedance within 200 and 2000 OHM

Trial Locations

Locations (1)

Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Nordrhein-Westfalen, Germany