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NCT03204864: Opsite 2

Optimization of Coronary Sinus Lead Placement Targeted to the Longest Right-to-Left Delay

Completed NA Last updated 11 September 2018
What this trial tests

NA trial testing RLD Group in HF Patient in 211 participants. Completed in 31 March 2018.

Timeline
1 March 2016
Primary endpoint
30 September 2017
31 March 2018

Quick facts

Lead sponsorMichele Brignole
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment211
Start date1 March 2016
Primary completion30 September 2017
Estimated completion31 March 2018
Sites4 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Michele Brignole

Who can join

Eligibility, any sex, with HF Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, multi-center, physician-initiated study, with intra-center control arm of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) with or without defibrillator therapy. The purpose of this study is to verify whether optimizing the left ventricular lead position at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV bipolar deflection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy.
    Oddone D, Solari D, Arena G, Mureddu R, et al · · 2019 · cited 4× · PMID 30508076 · DOI 10.1093/europace/euy275

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