Cardiac ResynchronizationBioCONTINUENCT02323503
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
An observational study of Cardiac Resynchronization and Biventricular Pacemakers, Artificial, run by Biotronik SE & Co. KG at 37 sites in 8 countries.
Trial summary
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable
- What is being tested?
- CRT-D device replacement
- Type of treatment
- Medical device
- How many people
- 289 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 9 Jun 2015to 12 Feb 2020
- How long will I take part?
- 2 Years
- 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 initially implanted with a CRT-D (cardiac resynchronization therapy with defibrillator) device for primary prevention indication for defibrillation, requiring a device replacement by another CRT-D because of battery depletion
Who may be able to join
- Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
- Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
- Lifetime of the previous CRT-D > 3 years
- Patient willing and able to comply with the protocol and who has provided written informed consent
- Patient whose medical situation is stable.
Who cannot join
- Patient with an ICD lead under advisory (e.g. Fidelis lead)
- Right or left ventricular leads exchange during CRT-D replacement
- Non functional atrial (except for patient with chronic AF) or right/left ventricular leads
- Life expectancy < 1 year
- Age < 18 years
- Pregnant woman or woman who plan to become pregnant during the trial
- Participation in another interventional clinical study
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
France22 sites
CH d'Annecy
Annecy
Hôpital de la Cavale Blanche
Brest
CHU Caen
Caen
CHU Montpied
Clermont-Ferrand
CH Du Bocage
Dijon
CHRU de Lille
Lille
CHU de Limoges
Limoges
CH Saint Philibert
Lomme
Cliniques du Tonkin, de la Sauvegarde et Protestante
Lyon
Clinique Clairval
Marseille
Hôpital de la Timone
Marseille
Hôpital Mercy
Metz
CHU Montpellier
Montpellier
CHU Nancy
Nancy
Nouvelles Cliniques Nantaises
Nantes
CH de la Pitié Salpétrière
Paris
CHU Pessac
Pessac
CHU de Rennes
Rennes
CHU Hôpital CHarles Nicolle
Rouen
CH de Saint-Etienne
Saint-Etienne
CHU Toulouse
Toulouse, 31403
CHU Tours
Tours
Germany4 sites
Schuechtermann-Klinik
Bad Rothenfelde
Stadtisches Klinikum Brandenburg
Brandenburg
DRK-Krankenhaus Moelln Ratzeburg
Ratzeburg
Cardiological Praxis
Rostock
Italy3 sites
Ospedale Versilia
Lido di Camaiore
Clinica Mediterranea
Naples
Ospedale Santa Chiara
Pisa
Spain3 sites
Hospital Universitario de Burgos
Burgos
Hospital Universitario Marques de Valdecilla
Santander
Hospital Clinico Universitario de Valladolid
Valladolid
About this study
Official title: BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.
80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.
So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
Read the detailed description
The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.
Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Being tested
- CRT-D device replacement
- Keywords
- CRT-D, replacement, primary prevention, ventricular tachyarrhythmias
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-D device replacementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the rate of patients with at least one sustained VTA after replacement
Measured: up to two years
Secondary outcomes (1)
Rate of patients with at least one VTA for 4 specific subgroups
Grp R[1-4]: LVEF ≥40% / <40% at the time of replacement and with / without previous VTA during the lifetime of their first CRT-D device
Measured: After the device replacement and after a minimum of two years follow-up (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start9 Jun 2015
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
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 Cardiac ResynchronizationStudies 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
- 289 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel DG Gras, MD, Principal investigator, Nouvelles Cliniques Nantaises, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323503
- Sponsor's protocol ID
- CR018
- Acronym
- BioCONTINUE
- Status last verified
- Jun 2019
- First submitted
- 18 Dec 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gras D, Clementy N, Ploux S, Guyomar Y, Legallois D, Segreti L, Blangy H, Laurent G, Bizeau O, Fauquembergue S, Lazarus A; BioCONTINUE study Investigators. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol. 2023 Aug;66(5):1201-1209. doi: 10.1007/s10840-022-01440-5. Epub 2022 Dec 2.
PubMed 36459310
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
- ClinicalTrials.gov ID
- NCT02323503
- Acronym / sponsor ID
- BioCONTINUE / CR018
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Keywords
- CRT-D, replacement, primary prevention, ventricular tachyarrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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 (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.
80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.
So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
Detailed description
The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.
Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initially implanted with a CRT-D (cardiac resynchronization therapy with defibrillator) device for primary prevention indication for defibrillation, requiring a device replacement by another CRT-D because of battery depletion
Key inclusion criteria (5 listed)
- Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
- Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
- Lifetime of the previous CRT-D > 3 years
- Patient willing and able to comply with the protocol and who has provided written informed consent
- Patient whose medical situation is stable.
Key exclusion criteria (7 listed)
- Patient with an ICD lead under advisory (e.g. Fidelis lead)
- Right or left ventricular leads exchange during CRT-D replacement
- Non functional atrial (except for patient with chronic AF) or right/left ventricular leads
- Life expectancy < 1 year
- Age < 18 years
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 |
|---|---|---|
| CRT-D device replacement | Device | – |
Primary outcome
Assess the rate of patients with at least one sustained VTA after replacement
Time frame: up to two years
1 secondary outcome
Rate of patients with at least one VTA for 4 specific subgroups
Time frame: After the device replacement and after a minimum of two years follow-up (FU)
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 31 Mar 2020.
- Derived from this study: PubMed 36459310Gras D, Clementy N, Ploux S, Guyomar Y, Legallois D, Segreti L, Blangy H, Laurent G, Bizeau O, Fauquembergue S, Lazarus A; BioCONTINUE study Investigators. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol. 2023 Aug;66(5):1201-1209. doi: 10.1007/s10840-022-01440-5. Epub 2022 Dec 2.
- Individual participant dataSharing planned: No
Related trials for Cardiac Resynchronization
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Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
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BIO|STREAM.CSP Study
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BIO|MASTER.CSP Study
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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
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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.
Daniel DG Gras, MD principal investigator
Nouvelles Cliniques Nantaises, France
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization and Biventricular Pacemakers, Artificial, run by Biotronik SE & Co. KG at 37 sites in 8 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 5 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Germany, Italy, Spain, Portugal and 3 more countries. 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?
Assess the rate of patients with at least one sustained VTA after replacement (time frame: up to two years). 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 NCT02323503, 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 31 Mar 2020.