Heart FailureNCT07077928
Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator
An observational study of Heart Failure and Ventricular Arrhythmias and Cardiac Arrest, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Arrhythmias and Cardiac Arrest
- What is being tested?
- Pacemaker upgrade
- Type of treatment
- Medical device
- How many people
- 307 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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,
Show all 23Show fewer
- 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.
Who cannot join
- patients with atrial fibrillation
- LV EF higher than 50 %
- NYHA Class 1
- Patients with active infection or cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Pacemaker upgrade
- Keywords
- Heart failure, Cardiac Resynchronization Therapy, Upgrade, Defibrillator, Pacemaker
- Medical subject headings
- Heart Failure, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker upgradeDevice
CRT upgrade
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality and hospitalization for heart failure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2019
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 307 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077928
- Sponsor's protocol ID
- Bursa PH CRT Upgrade
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator
- ClinicalTrials.gov ID
- NCT07077928
- Acronym / sponsor ID
- Bursa PH CRT Upgrade
- Keywords
- Heart failure, Cardiac Resynchronization Therapy, Upgrade, Defibrillator, Pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (23 listed)
- Sinus rhythm,
- age higher than 18,
- EF lower than 35%,
- New York Heart Association (NYHA) class II-IV,
- QRS >130 ms,
Key exclusion criteria (4 listed)
- patients with atrial fibrillation
- LV EF higher than 50 %
- NYHA Class 1
- Patients with active infection or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker upgradeCRT upgrade | Device | – |
Primary outcome
All cause mortality and hospitalization for heart failure
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ventricular Arrhythmias and Cardiac Arrest, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality and hospitalization for heart failure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.