Heart FailureNCT01185392
European Cardiac Resynchronisation Therapy Survey
An observational study of Heart Failure, run by Helse Stavanger HF.
Trial summary
The European CRT survey represents a joint initiative between two ESC associations; the Heart Failure Association and the European Heart Rhythm Association. The survey will be performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will handle the data collection and data analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 2,438 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients successfully implanted with a new CRT-P, CRT-D or upgrades during the inclusion period were eligible. The successful procedure itself identified the patient as a survey candidate. Patients screened but not successfully implanted were not entered into the survey. Ethics approval and written informed consent were obtained in countries where required.
Who may be able to join
- eligible patients for CRT-P or CRT-D.
Who cannot join
- none
About this study
The European CRT survey represents a joint initiative between two ESC associations; the Heart Failure Association and the European Heart Rhythm Association. The survey will be performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will handle the data collection and data analysis.
Read the detailed description
This European CRT Survey was initiated by the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the ESC in order to describe current European practice and routines associated with CRT-P/CRT-D implantations based on sample of patients enrolled in 13 countries. The data collected following implantation provides information including clinical characteristics, diagnostic criteria, implantation routines and techniques, adverse experience, and assessment of adherence to guideline recommendations. The single follow-up visit at 1 year (9-15 months) will provide information regarding short-term clinical outcomes.
The primary objective of this Survey is to describe current European practice based on a broad sampling in 13 countries. The information collected will enable practice between centres and countries to be compared and permit benchmarking with national and international practice. The survey provides valuable quality assurance assessment for individual centres, permits limited economic analyses and broadly evaluates adherence to guideline recommendations.
The following 13 European countries contributed patients to the survey: Austria, Belgium, France, Germany, Ireland, Israel, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and UK. Two national coordinators, one each from the fields of heart failure and electrophysiology, were selected and given the responsibility to facilitate recruitment in their respective countries.
Follow the link for complete list of the members of the Scientific Committee and national coordinators.
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronisation Therapy in Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe current European CRT implantation practice and there is a need to precisely quantify the extent of treatment failures, adverse experience and complications associated with implantation.
The Survey will capture data from patients receiving CRT-P/CRT-D devises:
- Demographics and clinical characteristics
- Diagnostic criteria assessed prior to implantation
- Pharmacological therapy at baseline and follow-up
- Implantation procedure and techniques
- Device programming
- Short and long-term outcomes
- Adverse experience and hospitalisation
- Economic analyses
- Adherence to guidelines
These data should also provide information contrasting practice between centres and countries and adherence to guideline recommendations.
Measured: November 2008-October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 2,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Boston Scientific Corporation, Medtronic, Abbott Medical Devices, Biotronik SE & Co. KG, LivaNova, Roche Diagnostic Ltd.
- Responsible party
- Sponsor
- Investigators
- Kenneth Dickstein, MD, PHD, Study chair, HFA of the ESCSilvia Priori, MD, PHD, Study chair, EHRA of the ESCAngelo Auricchio, MD, PHD, Study director, EHRA of the ESCJosep Brugada, MD, PHD, Study director, EHRA of the ESCJohn Cleland, MD, PHD, Study director, HFA of the ESCGeneviève Derumeaux, MD, PHD, Study director, EAE of the ESCDaniel Gras, MD, PHD, Study director, EHRA of the ESCMichel Komajda, MD, PHD, Study director, HFA of the ESC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185392
- Sponsor's protocol ID
- CRT Survey
- Status last verified
- Jun 2012
- First submitted
- 7 Aug 2010
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
CRT Survey Scientific Committee. European cardiac resynchronization therapy survey: rationale and design. Eur J Heart Fail. 2009 Mar;11(3):326-30. doi: 10.1093/eurjhf/hfp030.
PubMed 19228801Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators. The European cardiac resynchronization therapy survey. Eur Heart J. 2009 Oct;30(20):2450-60. doi: 10.1093/eurheartj/ehp359. Epub 2009 Aug 31.
PubMed 19723694Bogale N, Priori S, Cleland JG, Brugada J, Linde C, Auricchio A, van Veldhuisen DJ, Limbourg T, Gitt A, Gras D, Stellbrink C, Gasparini M, Metra M, Derumeaux G, Gadler F, Buga L, Dickstein K; Scientific Committee, National Coordinators, and Investigators. The European CRT Survey: 1 year (9-15 months) follow-up results. Eur J Heart Fail. 2012 Jan;14(1):61-73. doi: 10.1093/eurjhf/hfr158.
PubMed 22179034Bogale N, Witte K, Priori S, Cleland J, Auricchio A, Gadler F, Gitt A, Limbourg T, Linde C, Dickstein K; Scientific Committee, National coordinators and the investigators. The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades. Eur J Heart Fail. 2011 Sep;13(9):974-83. doi: 10.1093/eurjhf/hfr085. Epub 2011 Jul 19.
PubMed 21771823
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Cardiac Resynchronisation Therapy Survey
- ClinicalTrials.gov ID
- NCT01185392
- Acronym / sponsor ID
- CRT Survey
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronisation Therapy in Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,438 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Boston Scientific Corporation, Medtronic, Abbott Medical Devices, Biotronik SE & Co. KG, LivaNova, Roche Diagnostic Ltd.
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Aug 2010 (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 European CRT survey represents a joint initiative between two ESC associations; the Heart Failure Association and the European Heart Rhythm Association. The survey will be performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will handle the data collection and data analysis.
Detailed description
This European CRT Survey was initiated by the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the ESC in order to describe current European practice and routines associated with CRT-P/CRT-D implantations based on sample of patients enrolled in 13 countries. The data collected following implantation provides information including clinical characteristics, diagnostic criteria, implantation routines and techniques, adverse experience, and assessment of adherence to guideline recommendations. The single follow-up visit at 1 year (9-15 months) will provide information regarding short-term clinical outcomes.
The primary objective of this Survey is to describe current European practice based on a broad sampling in 13 countries. The information collected will enable practice between centres and countries to be compared and permit benchmarking with national and international practice. The survey provides valuable quality assurance assessment for individual centres, permits limited economic analyses and broadly evaluates adherence to guideline recommendations.
The following 13 European countries contributed patients to the survey: Austria, Belgium, France, Germany, Ireland, Israel, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and UK. Two national coordinators, one each from the fields of heart failure and electrophysiology, were selected and given the responsibility to facilitate recruitment in their respective countries.
Follow the link for complete list of the members of the Scientific Committee and national coordinators.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients successfully implanted with a new CRT-P, CRT-D or upgrades during the inclusion period were eligible. The successful procedure itself identified the patient as a survey candidate. Patients screened but not successfully implanted were not entered into the survey. Ethics approval and written informed consent were obtained in countries where required.
Key inclusion criteria (1 listed)
- eligible patients for CRT-P or CRT-D.
Key exclusion criteria (1 listed)
- none
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
To describe current European CRT implantation practice and there is a need to precisely quantify the extent of treatment failures, adverse experience and complications associated with implantation.
Time frame: November 2008-October 2010
The Survey will capture data from patients receiving CRT-P/CRT-D devises: * Demographics and clinical characteristics * Diagnostic criteria assessed prior to implantation * Pharmacological therapy at baseline and follow-up * Implantation procedure and techniques * Device programming * Short and long-term outcomes * Adverse experience and hospitalisation * Economic analyses * Adherence to guidelines These data should also provide information contrasting practice between centres and countries and adherence to guideline recommendations.
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 27 Jun 2024.
- Background: PubMed 19228801CRT Survey Scientific Committee. European cardiac resynchronization therapy survey: rationale and design. Eur J Heart Fail. 2009 Mar;11(3):326-30. doi: 10.1093/eurjhf/hfp030.
- Results publication: PubMed 19723694Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators. The European cardiac resynchronization therapy survey. Eur Heart J. 2009 Oct;30(20):2450-60. doi: 10.1093/eurheartj/ehp359. Epub 2009 Aug 31.
- Derived from this study: PubMed 22179034Bogale N, Priori S, Cleland JG, Brugada J, Linde C, Auricchio A, van Veldhuisen DJ, Limbourg T, Gitt A, Gras D, Stellbrink C, Gasparini M, Metra M, Derumeaux G, Gadler F, Buga L, Dickstein K; Scientific Committee, National Coordinators, and Investigators. The European CRT Survey: 1 year (9-15 months) follow-up results. Eur J Heart Fail. 2012 Jan;14(1):61-73. doi: 10.1093/eurjhf/hfr158.
- Derived from this study: PubMed 21771823Bogale N, Witte K, Priori S, Cleland J, Auricchio A, Gadler F, Gitt A, Limbourg T, Linde C, Dickstein K; Scientific Committee, National coordinators and the investigators. The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades. Eur J Heart Fail. 2011 Sep;13(9):974-83. doi: 10.1093/eurjhf/hfr085. Epub 2011 Jul 19.
- Synopsis of the Survey, list of participating countries and members of the Scientific Committee and national coordinatorsLink provided by the sponsor.
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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.
Kenneth Dickstein, MD, PHD study chair
HFA of the ESC
Silvia Priori, MD, PHD study chair
EHRA of the ESC
Angelo Auricchio, MD, PHD study director
EHRA of the ESC
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Helse Stavanger HF.
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 1 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
To describe current European CRT implantation practice and there is a need to precisely quantify the extent of treatment failures, adverse experience and complications associated with implantation. (time frame: November 2008-October 2010). 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 NCT01185392, which also lists 4 linked publications.
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 27 Jun 2024.