Atrial FibrillationPre-CRAFTNCT01930695
Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
An observational study of Atrial Fibrillation and Heart Failure, run by Biotronik SE & Co. KG at 5 sites in 2 countries.
Trial summary
The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- How many people
- 18 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2013to Oct 2014
- 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: Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation
Who may be able to join
- CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)
- Permanent atrial fibrillation
- Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T
- Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)
- Patient eligible for programming of DX functionality according to the physicians' decision
- Patient is willing and able to comply with the CIP and provided written informed consent
- Patient accepts Home Monitoring® concept and has sufficient GSM/GPRS coverage
Who cannot join
- Patients with any contraindication to CRT-D therapy
- Patients listed for heart transplantation
- Life expectancy less than 12 months
- Pregnant or breast-feeding women
- Patients under the age of 18
- Patients with limited contractual capability
- Participation in any other clinical study
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, 29549
St. Marien-Hospital Lünen
Lünen, 44534
Deutsches Herzzentrum München
München, 80636
DRK Mölln-Ratzeburg
Ratzeburg, 23909
About this study
The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- DX functionality, Atrial fibrillation, CRT-D indication
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of IEGM recording
to assess if the IEGM Online recordings of the Lumax 640/740 HF-T with DX functionality provide adequate quality to classify the atrial rhythm
Measured: 3 months
Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality
to assess the safety of the Lumax 640/740 HF-T by the analysis of Serious Adverse Device Effects which are related to the DX functionality
Measured: 3 months
Safety of the Lumax 640/740 HF-T with DX functionality based on all, serious and non-serious, Adverse Device Effects related to DX functionality
to assess the safety of the Lumax 640/740 HF-T with DX functionality by the analysis of all (serious and non-serious) Adverse Device Effects which are related to the DX functionality
Measured: 3 months
Number of patients with maintenance of diagnosis of permanent AF
to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 2014
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 Atrial FibrillationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christian Sticherling, Prof. Dr., Study chair, Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930695
- Sponsor's protocol ID
- CR013
- Acronym
- Pre-CRAFT
- Status last verified
- Apr 2018
- First submitted
- 21 Aug 2013
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sticherling C, Muller D, Schaer BA, Kruger S, Kolb C; Pre-CRAFT investigators. Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy. Indian Pacing Electrophysiol J. 2018 Jul-Aug;18(4):140-145. doi: 10.1016/j.ipej.2018.03.005. Epub 2018 Mar 27.
PubMed 29596906
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
- ClinicalTrials.gov ID
- NCT01930695
- Acronym / sponsor ID
- Pre-CRAFT / CR013
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- DX functionality, Atrial fibrillation, CRT-D indication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Aug 2013 (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.
The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation
Key inclusion criteria (7 listed)
- CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)
- Permanent atrial fibrillation
- Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T
- Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)
- Patient eligible for programming of DX functionality according to the physicians' decision
Key exclusion criteria (7 listed)
- Patients with any contraindication to CRT-D therapy
- Patients listed for heart transplantation
- Life expectancy less than 12 months
- Pregnant or breast-feeding women
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of IEGM recording
Time frame: 3 months
to assess if the IEGM Online recordings of the Lumax 640/740 HF-T with DX functionality provide adequate quality to classify the atrial rhythm
Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality
Time frame: 3 months
to assess the safety of the Lumax 640/740 HF-T by the analysis of Serious Adverse Device Effects which are related to the DX functionality
Safety of the Lumax 640/740 HF-T with DX functionality based on all, serious and non-serious, Adverse Device Effects related to DX functionality
Time frame: 3 months
to assess the safety of the Lumax 640/740 HF-T with DX functionality by the analysis of all (serious and non-serious) Adverse Device Effects which are related to the DX functionality
Number of patients with maintenance of diagnosis of permanent AF
Time frame: 3 months
to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation
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 11 Apr 2018.
- Results publication: PubMed 29596906Sticherling C, Muller D, Schaer BA, Kruger S, Kolb C; Pre-CRAFT investigators. Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy. Indian Pacing Electrophysiol J. 2018 Jul-Aug;18(4):140-145. doi: 10.1016/j.ipej.2018.03.005. Epub 2018 Mar 27.
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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.
Christian Sticherling, Prof. Dr. study chair
Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Heart Failure, run by Biotronik SE & Co. KG at 5 sites in 2 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 7 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 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. 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?
Quality of IEGM recording (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT01930695, 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 11 Apr 2018.