TachycardiaNCT01856491
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
A study testing RELIANCE 4-FRONT™ Passive Fixation lead implantation in people with Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 11 sites in 3 countries.
Trial summary
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- What is being tested?
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 16 Dec 2013to 13 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Willing and capable of providing informed consent
- Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
- Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead
- Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Mechanical tricuspid heart valve
- Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
- RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
- Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
Show all 10Show fewer
- Currently on the active heart transplant list
- Documented life expectancy of less than 12 months
- Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
- Currently requiring chronic dialysis
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Italy7 sites
Fondazione di Ricerca e Cura 'Giovanni Paolo II
Campobasso
Ospedale Alessandro Manzoni
Lecco, 23900
Clinica Mediterranea
Naples, 80121
Ospedale Buon Consiglio
Naples, 80123
Azienda Ospedaliero Universitaria Pisana
Pisa, 56127
Osp. Civile S. Maria Delle Grazie
Pozzuoli, 80078
Ospedale San Pietro Fatebenefratelli
Rome, 00189
Israel3 sites
Meir Medical Center
Kfar Saba, 44281
Beilinson Medical Center
Petah Tikva, 49100
Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
Read the detailed description
The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.
Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
- Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
- Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
- Sensed Amplitude at 3 Months Post-Implant
- Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT passive fixation lead.
Clinic visits will occur at:
- Enrollment Visit (no later than 30 days prior to implant procedure)
- Implant Procedure (Day 0; all future follow ups based on this date)
- Pre-Discharge Clinic Visit (3 - 72 hours post-implant)
- One Month Clinic Visit (30±7 days)
- 3 Month Clinic Visit (91 ± 21 days)
- 6 Month Clinic Visit (180 ± 30 days)
- 12 Month Clinic Visit (365 ± 45 days)
- 18 Month Clinic Visit (545± 45 days)
- 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.
Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Being tested
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Keywords
- RELIANCE 4-FRONT, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
- Medical subject headings
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELIANCE 4-FRONT™ Passive Fixation lead implantationDevice
Implantation of transvenous defibrillation lead with passive fixation mechanism.
| Study group | Role | What they receive |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Other | Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead Receives: Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Free Rate
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Measured: 3-months
Secondary outcomes (1)
Complication Free Rate
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Measured: 3 months through 15 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study start16 Dec 2013
- Primary completion2 Nov 2015
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Grazia Bongiorni, MD, Principal investigator, University Hospital Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856491
- Sponsor's protocol ID
- C1868
- Status last verified
- Apr 2019
- First submitted
- 15 May 2013
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
- ClinicalTrials.gov ID
- NCT01856491
- Acronym / sponsor ID
- C1868
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Keywords
- RELIANCE 4-FRONT, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 2 Nov 2015 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
Detailed description
The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.
Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
- Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
- Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
- Sensed Amplitude at 3 Months Post-Implant
- Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT passive fixation lead.
Clinic visits will occur at:
- Enrollment Visit (no later than 30 days prior to implant procedure)
- Implant Procedure (Day 0; all future follow ups based on this date)
- Pre-Discharge Clinic Visit (3 - 72 hours post-implant)
- One Month Clinic Visit (30±7 days)
- 3 Month Clinic Visit (91 ± 21 days)
- 6 Month Clinic Visit (180 ± 30 days)
- 12 Month Clinic Visit (365 ± 45 days)
- 18 Month Clinic Visit (545± 45 days)
- 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.
Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation | Other | Device: RELIANCE 4-FRONT™ Passive Fixation lead implantationSingle arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and capable of providing informed consent
- Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
- Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead
- Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (10 listed)
- Known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Mechanical tricuspid heart valve
- Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
- RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELIANCE 4-FRONT™ Passive Fixation lead implantationImplantation of transvenous defibrillation lead with passive fixation mechanism. | Device | RELIANCE 4-FRONT™ Passive Fixation |
Primary outcome
Complication Free Rate
Time frame: 3-months
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
1 secondary outcome
Complication Free Rate
Time frame: 3 months through 15 months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maria Grazia Bongiorni, MD principal investigator
University Hospital Pisa, Italy
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELIANCE 4-FRONT™ Passive Fixation lead implantation in people with Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 11 sites in 3 countries.
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 5 inclusion and 10 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Israel, 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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complication Free Rate (time frame: 3-months). 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 30 Apr 2019.