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Budapest Upgrade CRT Study (Version 009-4.1)

NCT02270840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-06-06

No results posted yet for this study

Summary

Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)

Conditions

Interventions

DEVICE

CRT-D

Biventricular upgrade. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Pharmahungary Group

    collaborator INDUSTRY

  • Semmelweis University Heart and Vascular Center

    lead OTHER

Principal Investigators

  • Valentina Kutyifa, MD · University of Rochester Medical Center, Rochester, NY, USA

  • Ilan Goldenberg, Prof. MD · Sheba Medical Center

  • Béla Merkely, Prof. MD · Semmelweis University Hearth and Vascular Center, Budapest, Hungary

  • Annamaria Kosztin, MD · Semmelweis University Hearth and Vascular Center, Budapest, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Germany
  • Hungary
  • Israel
  • Poland
  • Serbia
  • Slovakia
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02270840 on ClinicalTrials.gov