NCT07077928

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

July 12, 2025

Last Update Submit

July 12, 2025

Conditions

Keywords

Heart failureCardiac Resynchronization TherapyUpgradeDefibrillatorPacemaker

Outcome Measures

Primary Outcomes (1)

  • All cause mortality and hospitalization for heart failure

    24 months

Interventions

CRT upgrade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who consecutively underwent de novo CRT implantation, CRT upgrade, and DDDR ICD implantation at the Cardiology Clinic Heart failure group in Sinus rhythm

You may qualify if:

  • 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.
  • +8 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Hastanesi

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart FailureHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

January 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations