Heart FailureNCT01173783
Deutsches Device Qualitätsregister
An observational study of Heart Failure, run by Stiftung Institut fuer Herzinfarktforschung at 7 sites in Germany.
Trial summary
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 4,008 participants
- Where
- 7 sitesGermany
- Study dates
- Mar 2007to Aug 2011
- 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 with an intended implantation of an ICD / CRT.
Who may be able to join
- The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.
Who cannot join
- Missing signed informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Vivantes Klinikum Am Urban
Berlin, 10967
Städtische Kliniken Bielefeld
Bielefeld, 33526
St. Marien Hospital
Bonn, 53115
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Asklepios Klinik St Georg
Hamburg, 20099
St. Vincentius Klinikan AG
Karlsruhe, 76135
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, 78050
About this study
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.
Read the detailed description
The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac insufficiency, Implantable Cardioverter/Defibrillator, Cardiac Resynchronization therapy, ICD, CRT, Register
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
Measured: 01/03/2007-12/31/2011
Secondary outcomes (7)
Specification of the device and the realization of the implantation as well as the success of the operation
Measured: 01/03/2007-12/31/2011
Documentation of further interventions needed after the Index Event during hospital stay
Measured: 01/03/2007-12/31/2011
Documentation of hospital mortality and non-fatal complications
Measured: 01/03/2007-12/31/2011
Documentation of the 1-year mortality and non-fatal complications
Measured: 01/03/2007-12/31/2011
Documentation of the dispensary of shocks within one year
Measured: 01/03/2007-12/31/2011
Documentation of symptomatology and number of hospitalizations
Measured: 01/03/2007-12/31/2011
Documentation of medication therapy after 12 months
Measured: 01/03/2007-12/31/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startMar 2007
- Primary completionAug 2011
- Study completionAug 2011
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Senges, MD, Principal investigator, Stiftung Institut fuer Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173783
- Sponsor's protocol ID
- DEVICE
- Status last verified
- Jun 2016
- First submitted
- 29 Jul 2010
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deutsches Device Qualitätsregister
- ClinicalTrials.gov ID
- NCT01173783
- Acronym / sponsor ID
- DEVICE
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac insufficiency, Implantable Cardioverter/Defibrillator, Cardiac Resynchronization therapy, ICD, CRT, Register
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,008 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 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.
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.
Detailed description
The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consecutive patients with an intended implantation of an ICD / CRT.
Key inclusion criteria (1 listed)
- The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.
Key exclusion criteria (1 listed)
- Missing signed informed consent
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
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
Time frame: 01/03/2007-12/31/2011
7 secondary outcomes
Specification of the device and the realization of the implantation as well as the success of the operation
Time frame: 01/03/2007-12/31/2011
Documentation of further interventions needed after the Index Event during hospital stay
Time frame: 01/03/2007-12/31/2011
Documentation of hospital mortality and non-fatal complications
Time frame: 01/03/2007-12/31/2011
Documentation of the 1-year mortality and non-fatal complications
Time frame: 01/03/2007-12/31/2011
Documentation of the dispensary of shocks within one year
Time frame: 01/03/2007-12/31/2011
Documentation of symptomatology and number of hospitalizations
Time frame: 01/03/2007-12/31/2011
Documentation of medication therapy after 12 months
Time frame: 01/03/2007-12/31/2011
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 24 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Jochen Senges, MD principal investigator
Stiftung Institut fuer Herzinfarktforschung
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Stiftung Institut fuer Herzinfarktforschung at 7 sites in Germany.
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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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?
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany (time frame: 01/03/2007-12/31/2011). 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 24 Jun 2016.