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Prosthesis-Related InfectionsGAINE LASERNCT03121183

Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers

An observational study of Prosthesis-Related Infections and Equipment Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laser sheath and Implantable Cardiac Device lead extraction
How many people
45 participants
Where
1 siteFrance
Study dates
Mar 2015to Jun 2018
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: - Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

Who may be able to join

  • - Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

Who cannot join

  • - None

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers: a Retrospective Observational Study

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until >95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive.

Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.

Read the detailed description

The study will compare the strategies of percutaneous extraction to surgical extraction.

  • Mechanical percutaneous extraction is the conventional technique using locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue.
  • Laser-assisted lead extraction is most often used in complex procedures and dissolves rather than tear the scar tissue.
  • Sternotomy is the surgical procedure used when leads cannot be removed by percutaneous extraction. It is rarely employed.
Being tested
Laser sheath, Implantable Cardiac Device lead extraction
Keywords
Cardiology, Device Removal, Pacemaker, Defibrillators, Catheterization, Laser Therapy, Cost-Benefit Analysis
Medical subject headings
Prosthesis-Related Infections, Heart Failure, Arrhythmias, Cardiac, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser sheathDevice

    Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

  • Implantable Cardiac Device lead extractionBehavioural

    Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017

Study groups in NCT03121183
Study groupRoleWhat they receive
Patients who have undergone an extraction of implantable paceNot described
Receives: Device: Laser sheath; Behavioral: Implantable Cardiac Device lead extraction

What is being measured

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

  1. Direct medical cost

    Overall cost of care according to the hospital perspective: drug treatment, medical device, catheterization lab occupancy, operating room occupancy, medical and nursing staff time, hospitalization

    Measured: at day 1

Secondary outcomes (11)

  1. Investment cost for the hospital and damping

    annual projections: medical device and supplies

    Measured: at day 1

  2. Type of intervention

    mechanical percutaneous extraction, laser percutaneous extraction, surgical extraction

    Measured: at day 1

  3. Indication of the intervention

    infectious, technical failure or other

    Measured: at day 1

  4. Extracted leads characteristics

    number, type, age, failure

    Measured: at day 1

  5. Patient characteristics

    age, sex, origin (general hospital, university hospital, other)

    Measured: at day 1

  6. Number and type of complications

    tamponade, vascular rupture, haemothorax, equipment breakage, death…

    Measured: at day 1

  7. percutaneous extraction

    number of surgical transformation (sternotomy)

    Measured: at day 1

  8. Duration of hospitalization

    pre and post-extraction

    Measured: at day 1

  9. Duration of extraction procedure and fluoroscopy

    for percutaneous extraction

    Measured: at day 1

  10. quotation ranking of each patient for revenue valuation

    quotation ranking of each patient for revenue valuation

    Measured: at day 1

  11. Number of rehospitalization

    duration, cause and service

    Measured: at day 1

Timeline

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

  1. First posted20 Apr 2017
  2. Study startMar 2015
  3. Primary completionApr 2018 (estimated)
  4. Study completionJun 2018 (estimated)

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
Other
Time perspective
Retrospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121183
Sponsor's protocol ID
CHU-318
Acronym
GAINE LASER
Status last verified
Apr 2017
First submitted
14 Apr 2017
Last updated
1 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prosthesis-Related Infections and Equipment Failure, run by University Hospital, Clermont-Ferrand at 1 site 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: status not confirmed, as of the sponsor's last update on 1 Aug 2017. 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 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?

Results are not available in the source record.

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?

Direct medical cost (time frame: at day 1). 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 NCT03121183.

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 1 Aug 2017.

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