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Ventricular TachycardiaNCT00180349

Leader - Evaluation of Endotak Reliance

An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 25 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endotak Reliance
Type of treatment
Medical device
How many people
904 participants
Where
25 sitesFrance
Study dates
Dec 2004to Jul 2009
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: Consecutive patients with the indication for an implantable ICD are invited to participate.

Who may be able to join

  • ICD indication according to current guidelines with or without cardiac resynchronization therapy, being implanted with a Guidant ENDOTAK RELIANCE defibrillation lead as first implant, age above 18 years, able to understand the nature of the study and to be available for all follow-ups, having given consent in writing for anonymous data collection, life expectancy > 1 year.

Who cannot join

  • device replacement without concomitant implant of a Reliance defibrillation lead, pregnancy or of birth bearing age without contraception, participation in another clinical study, short life expectancy due to other medical conditions, not willing to sign the consent form, geographically unstable for a defibrillator follow-up as required per protocol, having a ventricular arrhythmia, that can be treated by drugs or surgery

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

France25 sites

  • CH Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • Hôpital Angoulème

    Angoulème, 16470

  • Clinique Cardiologique Aressy

    Aressy, 64320

  • CH Avignon

    Avignon, 84902

  • CHU du Morvan

    Brest, 29609

  • Hôpital Côte de Nacre

    Caen, 14033

  • CHU Henri Mondor

    Créteil, 94000

  • CHU Michalon

    Grenoble, 38043

  • CH Hôpital Nord

    Marseille, 13008

  • CHU La Timone

    Marseille, 13385

  • CHU Montpellier

    Montpellier, 34295

  • CHU Brabois

    Nancy

  • Nouvelle Clinique Nantaise

    Nantes, 44000

  • CHU Nantes

    Nantes, 44295

  • CHU Nice

    Nice, 06002

  • CHU D'Orleans

    Orléans, 45000

  • Clinique Bizet

    Paris

  • CHG Pau

    Pau, 64046

  • CHU Pontchaillou

    Rennes, 35033

  • CHU Rouen

    Rouen, 76031

  • Centre cardiologique du Nord

    Saint-Denis, 93000

  • CMC Arnaud Tzanck

    Saint-Laurent-du-Var, 6700

  • CHU Rangueil

    Toulouse, 31403

  • Clinique St. Gatien

    Tours, 37000

Other trials in France

About this study

Official title: Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads

The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

Read the detailed description

Baseline and clinical data were collected at inclusion, as were data on procedural characteristics, device implantation-related adverse events and device programming at the time of hospital discharge. Patients were subsequently divided in two groups: patients who underwent VF induction at implantation or before hospital discharge(VF induction group); and patients who did not undergo VF induction (untested group).The patients were followed up at 3-6 months and at12 months after the implantation. VF induction procedures were left to the investigator's discretion, but reasons for not performing a VF induction at implantation were recorded prospectively. ICD programming parameters for tachycardia or bradycardia were also left at the investigator's discretion.

Being tested
Endotak Reliance
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 RelianceDevice

    Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Defibrillation testing (DT) procedures and consequences on clinical outcomes

    to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during implantation

    Measured: at implant

  2. Defibrillation testing (DT) procedures and consequences on clinical outcomes

    to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during 1 year follow-up

    Measured: during 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
904 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00180349
Sponsor's protocol ID
Leader v. 1.0 10/04
Status last verified
Apr 2017
First submitted
12 Sep 2005
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 25 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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?

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?

Defibrillation testing (DT) procedures and consequences on clinical outcomes (time frame: at implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00180349.

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 Apr 2017.

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