SyncopeNCT03360227
Registry of Device Implantation
An observational study of Syncope and Bradycardia, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice. Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Syncope, Bradycardia, Tachycardia
- What is being tested?
- implantation of cardiac devices
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo cardiac device implantation in University Hospital Düsseldorf
Who may be able to join
- pre-operative clinical history taking
- pre-operative functional investigations (cardiac echo, electrocardiograms)
- pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC)
Who cannot join
- １. no written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hisaki Makimoto, MD contact
Germany1 site, 1 recruiting
- Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Hisaki Makimoto, MD
Rabea Wagstaff, M.A.
About this study
Official title: Registry of Device Implantation in University Hospital Duesseldorf
The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice.
Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field are still progressively developing. Not only these "traditional" implantable devices, there are multiple new devices for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and barostimulator.
The aim of this registry is to demonstrate the efficacy and the safety of standard device implantation procedures and to evaluate/ identify specific factors, including clinical characteristics, laboratory data and procedural data, which predict the prognosis/complication of the patients. These identification will result in further improvement of patients' care.
Read the detailed description
The implantation of cardiac devices has been one of the common standard procedures in the cardiac clinical practice.
Pacemakers are implanted for patients with symptomatic bradyarrhythmias. Implantable cardioverter-defibrillators are implanted in order to avoid sudden cardiac death (SCD) in high risk patients such as after myocardial infarction and reduced ejection fraction.
Cardiac resynchronization therapy was introduced to improve the prognosis in patients with reduced EF and left bundle branch block. This therapy demonstrated the efficacy in severe heart failure patients.
Recently a new implantable device has been developed also to improve the prognosis of patients with severe heart failure refractory to the maximal therapies at present. This barostimulator activates the baro-reflex and results in higher parasympathetic activity and better outcome in those patients, in whom the sympathetic function is overactivated.
In patients with cryptogenic stroke or syncope, the implantable loop recorder enables us to monitor the cardiac rhythm continuously for 3 years. With this device, the occult arrhythmias can be revealed and lead patients to the adequate therapy.
Above mentioned device therapies have been developed since 1960s, and the technologies in this field are still progressively developing. To catch up these advancements, the quality management including the efficacy, safety aspects and the prognosis of the patients should be carefully monitored.
The aim of the present study is, therefore, to demonstrate the efficacy and the safety of standard device implantation procedures. The patient specific and procedural factors are evaluated to test if those factors predict the prognosis of the patients. These identifications will eventually result in the improvement of future patients' care.
The data of patients who underwent device implantation since 2011 and those who undergo device implantation till 2019 will be collected, including the basic demographic data, comorbidities, results of laboratory and functional tests. In the latter patients, the peri-procedural data and post-procedural data are also prospectively collected.
The present study is essentially an observational study. The inclusion in this study does not affect the decision of device implantation itself. The post-procedural therapies, such as medications and device therapies are not due to this registry affected.
As a sub-project in this registry, biomarkers and thyroid hormone are evaluated to investigate the predictable value of those indices.
- Conditions
- Syncope, Bradycardia, Tachycardia, Sudden Cardiac Death, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- implantation of cardiac devices
- Keywords
- syncope, bradycardia, tachycardia, sudden cardiac death, implantable cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, biomarker, thyroid hormone
- Medical subject headings
- Syncope, Bradycardia, Tachycardia, Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of cardiac devicesDevice
implantation of cardiac devices
What is being measured
The primary outcome is the main question the study is designed to answer.
device related adverse events
Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission
Measured: during index hospital admission
Adverse Events
Adverse Events as occurrence of atrial fibrillation, occurrence of syncope, occurrence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or appropriate ICD therapy including antitachycardia pacing (ATP) and shock, occurrence of inadequate ICD therapy including ATP and shock in ICD/CRT-D patients, hospital admission due to cardiac disease and therapy, cardiac death
Measured: during index hospital admission
Secondary outcomes (4)
survival
Measured: 12 months
Clinical Events
free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm [defined as more than three VT episodes in 24 hours])
Measured: 12 months
hospitalization
hospitalization due to cardiac disease and therapy
Measured: 12 months
number of appropriate and inappropriate ICD therapies (ATP or shock)
number of appropriate and inappropriate ICD therapies (ATP or shock)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study startJan 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Hisaki Makimoto, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360227
- Sponsor's protocol ID
- 15-019
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Device Implantation in University Hospital Duesseldorf
- ClinicalTrials.gov ID
- NCT03360227
- Acronym / sponsor ID
- 15-019
- Conditions
- Syncope, Bradycardia, Tachycardia, Sudden Cardiac Death, Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- syncope, bradycardia, tachycardia, sudden cardiac death, implantable cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Dec 2017 (actual)
- 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 implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice.
Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field are still progressively developing. Not only these "traditional" implantable devices, there are multiple new devices for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and barostimulator.
The aim of this registry is to demonstrate the efficacy and the safety of standard device implantation procedures and to evaluate/ identify specific factors, including clinical characteristics, laboratory data and procedural data, which predict the prognosis/complication of the patients. These identification will result in further improvement of patients' care.
Detailed description
The implantation of cardiac devices has been one of the common standard procedures in the cardiac clinical practice.
Pacemakers are implanted for patients with symptomatic bradyarrhythmias. Implantable cardioverter-defibrillators are implanted in order to avoid sudden cardiac death (SCD) in high risk patients such as after myocardial infarction and reduced ejection fraction.
Cardiac resynchronization therapy was introduced to improve the prognosis in patients with reduced EF and left bundle branch block. This therapy demonstrated the efficacy in severe heart failure patients.
Recently a new implantable device has been developed also to improve the prognosis of patients with severe heart failure refractory to the maximal therapies at present. This barostimulator activates the baro-reflex and results in higher parasympathetic activity and better outcome in those patients, in whom the sympathetic function is overactivated.
In patients with cryptogenic stroke or syncope, the implantable loop recorder enables us to monitor the cardiac rhythm continuously for 3 years. With this device, the occult arrhythmias can be revealed and lead patients to the adequate therapy.
Above mentioned device therapies have been developed since 1960s, and the technologies in this field are still progressively developing. To catch up these advancements, the quality management including the efficacy, safety aspects and the prognosis of the patients should be carefully monitored.
The aim of the present study is, therefore, to demonstrate the efficacy and the safety of standard device implantation procedures. The patient specific and procedural factors are evaluated to test if those factors predict the prognosis of the patients. These identifications will eventually result in the improvement of future patients' care.
The data of patients who underwent device implantation since 2011 and those who undergo device implantation till 2019 will be collected, including the basic demographic data, comorbidities, results of laboratory and functional tests. In the latter patients, the peri-procedural data and post-procedural data are also prospectively collected.
The present study is essentially an observational study. The inclusion in this study does not affect the decision of device implantation itself. The post-procedural therapies, such as medications and device therapies are not due to this registry affected.
As a sub-project in this registry, biomarkers and thyroid hormone are evaluated to investigate the predictable value of those indices.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo cardiac device implantation in University Hospital Düsseldorf
Key inclusion criteria (3 listed)
- pre-operative clinical history taking
- pre-operative functional investigations (cardiac echo, electrocardiograms)
- pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC)
Key exclusion criteria (1 listed)
- １. no written 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantation of cardiac devicesimplantation of cardiac devices | Device | – |
Primary outcome
device related adverse events
Time frame: during index hospital admission
Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission
Adverse Events
Time frame: during index hospital admission
Adverse Events as occurrence of atrial fibrillation, occurrence of syncope, occurrence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or appropriate ICD therapy including antitachycardia pacing (ATP) and shock, occurrence of inadequate ICD therapy including ATP and shock in ICD/CRT-D patients, hospital admission due to cardiac disease and therapy, cardiac death
4 secondary outcomes
survival
Time frame: 12 months
Clinical Events
Time frame: 12 months
hospitalization
Time frame: 12 months
number of appropriate and inappropriate ICD therapies (ATP or shock)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
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.
Hisaki Makimoto, MD contact
Hisaki Makimoto, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Bradycardia, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hisaki Makimoto, MD (+492118118800), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
device related adverse events (time frame: during index hospital admission). The study lists 2 primary outcomes in all. 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 7 Feb 2020.