MedTrace Logo

Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study

NCT02066467 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 863

Last updated 2019-09-20

Study results available
· View outcomes & findings →

Summary

The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.

It is a prospective, non-randomized, observational multicenter study evaluating standard of care.

For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.

Study endpoints:

Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

Conditions

  • Heartfailure

Interventions

DEVICE

Left Ventricular lead implant: ACUITY X4® Lead Family

Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Haran Burri, Prof. · Hôpital Cantonal de Genève

  • Torsten Kayser · Boston Scientific Corporation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Austria
  • Belgium
  • Colombia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Singapore
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02066467 on ClinicalTrials.gov