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Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure

NCT03494933 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 959

Last updated 2023-08-03

No results posted yet for this study

Summary

The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to defibrillator (control group) with respect to all-cause mortality.

Conditions

Interventions

PROCEDURE

CRT-P implantation

Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-P device.

PROCEDURE

CRT-D implantation

Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-D device.

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Helios Health Institute GmbH

    lead OTHER

Principal Investigators

  • Gerhard Hindricks, MD · Heart Center Leipzig - University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-02-21
Completion
2023-02-21

Countries

  • Germany

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 NCT03494933 on ClinicalTrials.gov