ICD and CRT-D Indicated Patients4-SITE FFNCT00920452
The 4-SITE Field Following Study (4-SITE FF)
An observational study of ICD and CRT-D Indicated Patients, run by Guidant Corporation at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD and CRT-D Indicated Patients
- How many people
- 430 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, D - 32545
About this study
Official title: RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)
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.
Read the 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)
- Model Number: P108 (Quadripolar, IS-1, IS-1)
- RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)
- Conditions
- ICD and CRT-D Indicated Patients
- Keywords
- implantable cardioverter defibrillator (ICD), defibrillation leads, cardiac resynchronization therapy (CRT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate Detection of induced VT
Induced mean VT/VF detection time < 4.5 seconds
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: entire duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICD and CRT-D Indicated PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920452
- Sponsor's protocol ID
- 4-SITE FF 0209
- Acronym
- 4-SITE FF
- Status last verified
- Nov 2010
- First submitted
- 12 Jun 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)
- ClinicalTrials.gov ID
- NCT00920452
- Acronym / sponsor ID
- 4-SITE FF / 4-SITE FF 0209
- Conditions
- ICD and CRT-D Indicated Patients
- Keywords
- implantable cardioverter defibrillator (ICD), defibrillation leads, cardiac resynchronization therapy (CRT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (15 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Appropriate Detection of induced VT
Time frame: At Implant or during VT/VF testing up to one month after implant
Induced mean VT/VF detection time < 4.5 seconds
Appropriate induced VT/VF Shock Conversion
Time frame: 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 pacing thresholds at follow-up with the 4-SITE defibrillation leads
Time frame: 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
Time frame: 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
Appropriate sensing and absence of artefacts
Time frame: entire duration of study
Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD and CRT-D Indicated Patients, run by Guidant Corporation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate Detection of induced VT (time frame: At Implant or during VT/VF testing up to one month after implant). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.