RELIANCE Quadripolar Defibrillation leads (4-site) Field Following

RELIANCE Quadripolar Defibrillation leads (4-site) Field Following - The 4-SITE Field Following Study (4-SITE FF)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33403

Enrollment

Registered

2009-04-27

Start date

2009-05-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachyarrhythmia's - cardiac rythm disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to evaluate appropriate performance of the RELIANCE 4-SITE defibrillation lead and of the new 4-SITE Header / Lead interface by demonstrating - appropriate detection and shock conversion of induced Ventricular tachyarrhythmia*s (VT/VF) -appropriate pacing thresholds, shock and pacing lead Impedances at follow-up as a measure of lead integrity over 12 month time, and - Appropriate sensing and absence of artefacts / non-sustained / sustained episodes resulting from transient potentials (artefacts) originating from incomplete lead / header contact.	—

Measure

Time frame

The primary objective of this study is to evaluate appropriate performance of the RELIANCE 4-SITE defibrillation lead and of the new 4-SITE Header / Lead interface by demonstrating - appropriate detection and shock conversion of induced Ventricular tachyarrhythmia*s (VT/VF) -appropriate pacing thresholds, shock and pacing lead Impedances at follow-up as a measure of lead integrity over 12 month time, and - Appropriate sensing and absence of artefacts / non-sustained / sustained episodes resulting from transient potentials (artefacts) originating from incomplete lead / header contact.

—

Secondary

Measure	Time frame
The secondary objectives are to document Implant Experience by collecting and analyzing information regarding 4-Site system handling, and to answer clinical questions by performing different types of retrospective analysis of study data.	—

Countries

Netherlands

Outcome results