Skip to main content
OpenTrials
Completed

NCT Number: NCT07077928

Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator

Patients who consecutively underwent de novo CRT implantation, CRT upgrade, and DDDR ICD implantation at the Cardiology Clinic of Bursa Postgraduate Hospital between January 2019 and December 2023 according to the European Society of Cardiology (ESC) guideline criteria were included in the study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yüksek İhtisas Hastanesi

Bursa, Turkey (Türkiye)

About this study

100 patients receiving de-novo CRT, 38 patients upgrading from RV pacing to CRT, and 169 patients receiving a DDDR-ICD implantation were included the study. Inclusion criteria were left ventricular ejection fraction lower than 35% and either QRS longer than 130ms for CRT groups or QRS≤120ms for the DDDR-ICD group. Primary endpoints were all-cause mortality and hospitalization for heart failure during a follow-up period extending up to 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

De novo CRT group:

  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • New York Heart Association (NYHA) class II-IV,
  • QRS >130 ms,
  • patients with atrial fibrillation (AF) who converted to sinus rhythm and who remained symptomatic despite 3-6 months of guideline-directed medical therapy.

CRT upgrade group:

  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • NYHA class II-IV,
  • QRS duration >130 ms with RV pacing,

-> 20% RV pacing rate,

  • patients with AF who converted to sinus rhythm, at least 6 months since pacemaker implantation, and symptomatic despite 3-6 months of guideline directed medical therapy.

DDDR ICD group:

  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • QRS ≤120 ms,
  • NYHA class II-IV,
  • patients with AF converted to sinus rhythm,
  • receiving guideline-directed medical therapy.

Exclusion criteria

  • patients with atrial fibrillation
  • LV EF higher than 50 %
  • NYHA Class 1
  • Patients with active infection or cancer

Treatment and study plan

Pacemaker upgrade

Device

CRT upgrade

Primary outcomes

  1. All cause mortality and hospitalization for heart failure

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Bursa Postgraduate Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.