Ventricular TachycardiaNCT00180297
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
A study testing Endotak Reliance G in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 18 sites in France.
Trial summary
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Endotak Reliance G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 18 sitesFrance
- Study dates
- Apr 2005to Sep 2012
- 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
- ICD indication according to current Guidelines
Who cannot join
- Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CH Amiens
Amiens, 80054
CHU Angers
Angers, 49033
CH Besancon
Besançon, 25030
CHU Clermont Ferrand
Clermont-Ferrand, 63003
CHU Henri Mandor
Créteil, 94010
CHU Michalon
Grenoble, 38043
CH St. Joseph
Marseille, 13008
CHU La Timone
Marseille, 13385
CHU Montpellier
Montpellier, 34295
CHU Nantes
Nantes, 34295
Nouvelle Clinique Nantaise
Nantes, 34295
CHU Lariboisière
Paris, 75010
CHU Pitié Salpitrière
Paris, 75013
HEGP
Paris, 75908
Hôpital Pontchaillou
Rennes
CHU Rouen
Rouen, 76031
CHU Rangueil
Toulouse, 31403
CHU Tours
Tours, 37044
About this study
Official title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
Read the detailed description
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Endotak Reliance G
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotak Reliance GDevice
Reliance G is a defibrillation lead to be placed in the right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Mid septal site location | Experimental | RV lead is placed at mid septum. Receives: Device: Endotak Reliance G |
| Apical site location | Active comparator | RV lead is placed in apical position Receives: Device: Endotak Reliance G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Success Rate at Septal Site
Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
Measured: At implant
Secondary outcomes (5)
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
Measured: 3 months, 6 months, 12 months, 36 months, 60 months
The Rate of ATP Success Therapy
in VT zone with at least one efficient ATP
Measured: 3 months, 6 months, 12 months, 36 months, 60 months
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Measured: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Measured: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Evolution of Left Ventricular Ejection Fraction
LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2012
- Study completionSep 2012
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 Ventricular 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
- Investigators
- Philippe Mabo, MD, Principal investigator, Hôpital Pontchaillou, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180297
- Sponsor's protocol ID
- Septal 1.1 / 14.04.2005
- Other IDs
- 2004/12/012
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2005
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.
- ClinicalTrials.gov ID
- NCT00180297
- Acronym / sponsor ID
- Septal 1.1 / 14.04.2005
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- Apr 2005
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 1 Jul 2021
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 determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
Detailed description
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mid septal site location | Experimental | Device: Endotak Reliance GRV lead is placed at mid septum. |
| Apical site location | Active comparator | Device: Endotak Reliance GRV lead is placed in apical position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICD indication according to current Guidelines
Key exclusion criteria (1 listed)
- Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
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 |
|---|---|---|
| Endotak Reliance GReliance G is a defibrillation lead to be placed in the right ventricle. | Device | Apical site location, Mid septal site location |
Primary outcome
Implant Success Rate at Septal Site
Time frame: At implant
Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
5 secondary outcomes
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
Time frame: 3 months, 6 months, 12 months, 36 months, 60 months
The Rate of ATP Success Therapy
Time frame: 3 months, 6 months, 12 months, 36 months, 60 months
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Evolution of Left Ventricular Ejection Fraction
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Philippe Mabo, MD principal investigator
Hôpital Pontchaillou, Rennes, France
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotak Reliance G in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 18 sites in France.
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 1 inclusion and 1 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. 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 1 Jul 2021). 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?
Implant Success Rate at Septal Site (time frame: At implant). 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 14 Oct 2021.