Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm (BIO|REDUCE)

April 7, 2025 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Kepler University Clinic
  • Czechia
      • Králová, Czechia
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia
        • Fakultni Nemocnice Olomouc
  • Germany
      • Bad Neustadt An Der Saale, Germany
        • RHON-KLINIKUM Campus Bad Neustadt
      • Berlin, Germany
        • Vivantes Humboldt-Klinikum
      • Berlin-Steglitz, Germany
        • Charitè University Clinic, Campus Benjamin Franklin
      • Dresden, Germany
        • Herzzentrum Dresden Univesity Clinic at Technical University Dresden
      • Dresden, Germany
        • Städtisches Klinikum Dresden, Friedrichstadt
      • Düsseldorf, Germany
        • Heinrich-Heine University Düsseldorf
      • Erlangen, Germany
        • University Clinic Erlangen
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen
      • Kaiserslautern, Germany
        • Westpfalz-Klinikum
      • Kiel, Germany
        • University Clinic SH Campus Kiel
      • Leipzig, Germany
        • Clinic St. Georg
      • Munich, Germany
        • DHM
      • Neuss, Germany
        • Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss
      • Papenburg, Germany
        • Marien Hospital Papenburg Aschendorf
      • Rostock, Germany
        • Cardio Consil GmbH
      • Rothenburg Ob Der Tauber, Germany
        • Krankenhaus Rothenburg ob der Tauber
      • Würzburg, Germany
        • University Clinic Würzburg
  • Hungary
      • Budapest, Hungary
        • Semmelweis Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
single arm: CRT-DX
Device: Cardiac Resynchronization Therapy (CRT)
Observation and documentation of CRT patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
through study completion, on average 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of post-operative system revisions requiring an invasive re-intervention
Time Frame: through study completion, on average 12 months
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
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
through study completion, on average 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Documentation of patient characteristics and medication
Time Frame: through study completion, on average 12 months
through study completion, on average 12 months
Assessment of patients benefit from CRT
Time Frame: Baseline, 3, 6 and 12 months
Documentation of NYHA class
Baseline, 3, 6 and 12 months
Documentation of atrial sensing amplitude
Time Frame: through study completion, on average 12 months
through study completion, on average 12 months
Documentation of programming of a non-AV-sequential pacing mode (e.g. VVI) except if justified by atrial fibrillation
Time Frame: through study completion, on average 12 months
through study completion, on average 12 months
Number of serious adverse events
Time Frame: through study completion, on average 12 months
Documentation of serious adverse events
through study completion, on average 12 months
Documentation of implantation data
Time Frame: through study completion, on average 12 months
e.g. implantation time, x-ray exposure time, lead position
through study completion, on average 12 months
Echocardiographic changes - LVEF
Time Frame: Baseline, 6 and 12 months (optional at other visits)
Echocardiography (measurements of Left ventricular ejection fraction [%] )
Baseline, 6 and 12 months (optional at other visits)
Echocardiographic changes - LVESV/LVEDV
Time Frame: Baseline, 6 and 12 months (optional at other visits)
Echocardiography (optional measurements Left ventricular end-systolic/diatolic volume [ml])
Baseline, 6 and 12 months (optional at other visits)
Echocardiographic changes - LVESD/LVEDD
Time Frame: Baseline, 6 and 12 months (optional at other visits)
Echocardiography (optional measurements Left ventricular end-systolic/diastolic diameter [mm])
Baseline, 6 and 12 months (optional at other visits)
Echocardiographic changes - LAV
Time Frame: Baseline, 6 and 12 months (optional at other visits)
Echocardiography (optional measurements Left atrial volume [ml])
Baseline, 6 and 12 months (optional at other visits)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christof Kolb, Prof., DHM, München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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