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GAINE LASER
Sponsor study identifier
observational
45
1 country
1
Study Start
March 2015
Actual (reported)Primary Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Actual (reported)April 14, 2017
Actual (reported)April 20, 2017
Actual (reported)April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
at day 1
Investment cost for the hospital and damping
at day 1
Type of intervention
at day 1
Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017
Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017
\- Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
David BALAYSSAC
University Hospital, Clermont-Ferrand
45 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2017
First Posted
April 20, 2017
Study Start
March 2015
Actual (reported)Indication of the intervention
at day 1
Extracted leads characteristics
at day 1
Patient characteristics
at day 1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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