Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
NCT ID: NCT06455566
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2024-05-01
2027-05-01
Brief Summary
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The aims of this registry are the following :
* evaluate the feasibility of RIJ access for LP implantation;
* confirm the acute and chronic safety of RIJ access for LP implantation;
* compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;
* evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Leadless pacemaker implantation through right internal jugular vein
Leadless pacemaker implantation through right internal jugular vein
Leadless pacemaker implantation through right internal jugular vein
Interventions
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Leadless pacemaker implantation through right internal jugular vein
Leadless pacemaker implantation through right internal jugular vein
Eligibility Criteria
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Inclusion Criteria
* Eligible to leadless pacemaker
Exclusion Criteria
* Age \< 18 year-old
* Patient already included in a clinical study
18 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Angers University Hospital
Angers, , France
Caen University Hospital
Caen, , France
Grenoble University Hospital
Grenoble, , France
Lille University Hospital
Lille, , France
Lyon University Hospital
Lyon, , France
Metz-Thionville Regional Hospital
Metz, , France
Le Millénaire Private Hospital
Montpellier, , France
Les Franciscaines Private Hospital
Nîmes, , France
Rennes University Hospital
Rennes, , France
La Réunion University Hospital
Saint Pierre de La Réunion, , France
Strasbourg University Hospital
Strasbourg, , France
Toulouse University Hospital
Toulouse, , France
Tours University Hospital
Tours, , France
Countries
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References
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El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101.
Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25.
Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.
Other Identifiers
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RYTHMO-2024-01
Identifier Type: -
Identifier Source: org_study_id
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