Heart FailureBIO|REDUCENCT03839121
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Biotronik SE & Co. KG at 21 sites in 4 countries.
Trial summary
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- Cardiac Resynchronization Therapy (CRT)
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 1 Apr 2019to 8 Jun 2023
- 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 with Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication according to the current guidelines, who are in sinus rhythm without history of persistent or permanent atrial fibrillation (AF) and do not require right atrial (RA) lead implantation at study enrolment.
Who may be able to join
- Patient is able to understand the nature of study and has provided written informed consent.
- Patient is willing and able to perform all follow up visits at the study site.
- Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
- CRT-D is indicated according to the current ESC guidelines.
- De novo implantation with no pre-existing defibrillator or pacemaker system
- Patient is in sinus rhythm without history of persistent or permanent atrial fibrillation.
Show all 11Show fewer
- Patient has no atrioventricular (AV) block II or III.
- Patient has no evidence of impaired sinus node function.
- Patient has no need for atrial stimulation, has a resting heart rate (HR) > 40 b.p.m and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment
- NYHA class II or III
- Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment
Who cannot join
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
- Patient is participating in an interventional clinical investigation.
- Life-expectancy is less than 1 year.
- Patient has tachycardia-bradycardia syndrome
- Any standard contraindication for CRT-D
- Frequent premature ventricular contractions (PVC rate > 5 %/h) examined within 3 months prior to enrollment by appropriate routine method (e.g. 24 h holter electrocardiogram)
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Germany17 sites
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale
Vivantes Humboldt-Klinikum
Berlin
Herzzentrum Dresden Univesity Clinic at Technical University Dresden
Dresden
Städtisches Klinikum Dresden, Friedrichstadt
Dresden
Heinrich-Heine University Düsseldorf
Düsseldorf
University Clinic Erlangen
Erlangen
Elisabeth-Krankenhaus Essen
Essen
Westpfalz-Klinikum
Kaiserslautern
University Clinic SH Campus Kiel
Kiel
Clinic St. Georg
Leipzig
DHM
Munich
Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss
Neuss
Marien Hospital Papenburg Aschendorf
Papenburg
Cardio Consil GmbH
Rostock
Krankenhaus Rothenburg ob der Tauber
Rothenburg upon Tauber
Charitè University Clinic, Campus Benjamin Franklin
Steglitz
University Clinic Würzburg
Würzburg
Czechia2 sites
Fakultni Nemocnice Hradec Králové
Králová
Fakultni Nemocnice Olomouc
Olomouc
About this study
Official title: BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- Cardiac Resynchronization Therapy (CRT)
- Keywords
- Heart Diseases, CRT-D
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy (CRT)Device
Observation and documentation of CRT patients
| Study group | Role | What they receive |
|---|---|---|
| single arm: CRT-DX | Not described Receives: Device: Cardiac Resynchronization Therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of implantation of a right atrial lead after conclusion of the initial study device implantation
Measured: through study completion, on average 12 months
Secondary outcomes (3)
Number of post-operative system revisions requiring an invasive re-intervention
Measured: through study completion, on average 12 months
Number of lead complications requiring an invasive re-intervention
Measured: through study completion, on average 12 months
Number of device or pocket infections requiring an invasive re-intervention
Measured: through study completion, on average 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Apr 2019
- Primary completion8 Jun 2023
- Study completion8 Jun 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
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christof Kolb, Prof., Principal investigator, DHM, München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839121
- Sponsor's protocol ID
- CR024
- Acronym
- BIO|REDUCE
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction
- ClinicalTrials.gov ID
- NCT03839121
- Acronym / sponsor ID
- BIO|REDUCE / CR024
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Keywords
- Heart Diseases, CRT-D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 15 Feb 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.
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm: CRT-DX | – | Device: Cardiac Resynchronization Therapy (CRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication according to the current guidelines, who are in sinus rhythm without history of persistent or permanent atrial fibrillation (AF) and do not require right atrial (RA) lead implantation at study enrolment.
Key inclusion criteria (11 listed)
- Patient is able to understand the nature of study and has provided written informed consent.
- Patient is willing and able to perform all follow up visits at the study site.
- Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
- CRT-D is indicated according to the current ESC guidelines.
- De novo implantation with no pre-existing defibrillator or pacemaker system
Key exclusion criteria (7 listed)
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
- Patient is participating in an interventional clinical investigation.
- Life-expectancy is less than 1 year.
- Patient has tachycardia-bradycardia syndrome
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 |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT)Observation and documentation of CRT patients | Device | single arm: CRT-DX |
Primary outcome
Number of implantation of a right atrial lead after conclusion of the initial study device implantation
Time frame: through study completion, on average 12 months
3 secondary outcomes
Number of post-operative system revisions requiring an invasive re-intervention
Time frame: through study completion, on average 12 months
Number of lead complications requiring an invasive re-intervention
Time frame: through study completion, on average 12 months
Number of device or pocket infections requiring an invasive re-intervention
Time frame: through study completion, on average 12 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 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Christof Kolb, Prof. principal investigator
DHM, München
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Biotronik SE & Co. KG at 21 sites in 4 countries.
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 11 inclusion and 7 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Czechia, Austria, Hungary. 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?
Number of implantation of a right atrial lead after conclusion of the initial study device implantation (time frame: through study completion, on average 12 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 9 Apr 2025.