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

NCT03204864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2018-09-11

No results posted yet for this study

Summary

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.

Conditions

  • HF Patient

Interventions

DEVICE

RLD Group

patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold.

DEVICE

Conventional CS lead placement

Clinical Practice

Sponsors & Collaborators

  • Michele Brignole

    lead OTHER

Principal Investigators

  • Michele Brignole, MD · Ospedale del Tigullio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-09-30
Completion
2018-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204864 on ClinicalTrials.gov