Systolic Heart FailureNCT04065893
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
An observational study of Systolic Heart Failure and Ventricular Premature Complexes, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure, Ventricular Premature Complexes, Ventricular Tachycardia
- What is being tested?
- Catheter ablation of ventricular arrhythmia and Intensified medical therapy
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 1 Aug 2021
- 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
- Adult, Older adult
Study population: Pts. with systolic heart failure, wide QRS complex and CRT with reduced biventricular pacing due to ventricular arrhythmia (PVC/VT)
Who may be able to join
- reduced biventricular pacing <98% due to ventricular arrhythmia
Who cannot join
- reduced biventricular pacing <98% due to other cause
- age <18
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%.
Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.
- Conditions
- Systolic Heart Failure, Ventricular Premature Complexes, Ventricular Tachycardia, Cardiac Resynchronization Therapy, Reduced Biventricular Pacing
- Being tested
- Catheter ablation of ventricular arrhythmia, Intensified medical therapy
- Medical subject headings
- Heart Failure, Systolic, Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation of ventricular arrhythmiaProcedure or surgery
PVC or VT ablation
Intensified medical therapyDrug
Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation group | Patients with reduced biventricular pacing due to PVC or VT receiving catheter ablation of PVC/VT according to guidelines and clinical practices Receives: Procedure: Catheter ablation of ventricular arrhythmia | |
| Medical treatment group | Patients with reduced biventricular pacing due to PVC or VT receiving intensified medical therapy (antiarrhythmics/betablocker) according to guidelines and clinical practices Receives: Drug: Intensified medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Biventricular pacing
Influence of intervention (Ablation/medical treatment) on previously reduced biventricular pacing percentage (<98%). Biventricular pacing is measured in percentage of stimulation and is monitored at routine device interrogation.
Measured: 3 month after intervention biventricular pacing (%) is routinely monitored
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Sep 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065893
- Sponsor's protocol ID
- CRT-Bivent.
- Status last verified
- Nov 2021
- First submitted
- 16 Aug 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Bruck JH, Middeldorp M, Sultan A, Scheurlen C, Seuthe K, Wormann J, Filipovic K, Kadhim K, Sanders P, Steven D, Luker J. Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2023 Mar;66(2):353-361. doi: 10.1007/s10840-022-01259-0. Epub 2022 Jun 14.
PubMed 35697890
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT04065893
- Acronym / sponsor ID
- CRT-Bivent.
- Conditions
- Systolic Heart Failure, Ventricular Premature Complexes, Ventricular Tachycardia, Cardiac Resynchronization Therapy, Reduced Biventricular Pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Aug 2019 (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.
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%.
Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation group | – | Procedure: Catheter ablation of ventricular arrhythmiaPatients with reduced biventricular pacing due to PVC or VT receiving catheter ablation of PVC/VT according to guidelines and clinical practices |
| Medical treatment group | – | Drug: Intensified medical therapyPatients with reduced biventricular pacing due to PVC or VT receiving intensified medical therapy (antiarrhythmics/betablocker) according to guidelines and clinical practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pts. with systolic heart failure, wide QRS complex and CRT with reduced biventricular pacing due to ventricular arrhythmia (PVC/VT)
Key inclusion criteria (1 listed)
- reduced biventricular pacing <98% due to ventricular arrhythmia
Key exclusion criteria (3 listed)
- reduced biventricular pacing <98% due to other cause
- age <18
- pregnancy
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 |
|---|---|---|
| Catheter ablation of ventricular arrhythmiaPVC or VT ablation | Procedure or surgery | Catheter ablation group |
| Intensified medical therapyDosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice | Drug | Medical treatment group |
Primary outcome
Percentage of Biventricular pacing
Time frame: 3 month after intervention biventricular pacing (%) is routinely monitored
Influence of intervention (Ablation/medical treatment) on previously reduced biventricular pacing percentage (<98%). Biventricular pacing is measured in percentage of stimulation and is monitored at routine device interrogation.
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 15 Nov 2021.
- Derived from this study: PubMed 35697890van den Bruck JH, Middeldorp M, Sultan A, Scheurlen C, Seuthe K, Wormann J, Filipovic K, Kadhim K, Sanders P, Steven D, Luker J. Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2023 Mar;66(2):353-361. doi: 10.1007/s10840-022-01259-0. Epub 2022 Jun 14.
- 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 Systolic Heart Failure and Ventricular Premature Complexes, run by Universitätsklinikum Köln at 1 site in Germany.
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 1 inclusion and 3 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 15 Nov 2021. 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 Germany. 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?
Percentage of Biventricular pacing (time frame: 3 month after intervention biventricular pacing (%) is routinely monitored). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065893, which also lists 1 linked publication.
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 15 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.