Cardiac InsufficiencyNCT03083301
Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe
An observational study of Cardiac Insufficiency, run by Pierre Wauthy at 1 site in Belgium.
Trial summary
Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Insufficiency
- What is being tested?
- Medical Files data extraction
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2017to 29 May 2018
- 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 with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department.
Who may be able to join
- Patient who underwent cardiac resynchronization within the Brugmann University Hospital from 2003 til July 2016
- Cardiac insufficiency, whatever the origin, demonstrated by a cardiologist with demonstrated ventricular asynchronism.
- With left ventricular ejection fraction <35%
- And / or a left ventricular diastolic diastolic diameter> 55 mm
- And / or QRS measuring> 130 milli sec
- And / or left branch block
- Redo procedure on a pacemaker
Who cannot join
- Change of case on a patient who has already benefited from a triple chamber stimulator
Trial locations and contacts
1 site in 1 country.
About this study
Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA.
It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. Its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers, ARA2 (Sartans), spironolactone or digoxin.
Read more
When the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.The first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. It is the placement of this third one that often causes trouble. It is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. When the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.
The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed.
The aim of this study is to evaluate the immediate impact of this surgical management within the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.The hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.
- Conditions
- Cardiac Insufficiency
- Being tested
- Medical Files data extraction
- Keywords
- Cardiac resynchronisation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Files data extractionOther
Medical Files data extraction
| Study group | Role | What they receive |
|---|---|---|
| Cardiac insufficiency | Patients with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department Receives: Other: Medical Files data extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct failure rate of the mixed approach
Direct failure rate of the mixed approach
Measured: 7 years
Demographic data
Demographic data (descriptive analysis)
Measured: 7 years
Risks factors
Descriptive analysis of the risks factors linked to the failure of the procedure
Measured: 7 years
Type of cardiopathy
Type of cardiopathy
Measured: 7 years
PR interval
PR interval
Measured: 7 years
QRS interval
QRS interval
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Apr 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InsufficiencyStudies 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
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Pierre Wauthy, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083301
- Sponsor's protocol ID
- CHUB-cardiac resynchronization
- Status last verified
- May 2018
- First submitted
- 8 Mar 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe
- ClinicalTrials.gov ID
- NCT03083301
- Acronym / sponsor ID
- CHUB-cardiac resynchronization
- Conditions
- Cardiac Insufficiency
- Keywords
- Cardiac resynchronisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 20 Mar 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.
Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA.
It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. Its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers, ARA2 (Sartans), spironolactone or digoxin.
When the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.The first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. It is the placement of this third one that often causes trouble. It is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. When the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.
The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed.
The aim of this study is to evaluate the immediate impact of this surgical management within the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.The hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac insufficiency | – | Other: Medical Files data extractionPatients with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiac insufficiency (i.e in NYHA class III or IV) or refractory to optimal medical treatment (155 patients since 2003) in the Brugmann University Hospital, in the cardiac surgery department.
Key inclusion criteria (7 listed)
- Patient who underwent cardiac resynchronization within the Brugmann University Hospital from 2003 til July 2016
- Cardiac insufficiency, whatever the origin, demonstrated by a cardiologist with demonstrated ventricular asynchronism.
- Redo procedure on a pacemaker
Key exclusion criteria (1 listed)
- Change of case on a patient who has already benefited from a triple chamber stimulator
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 |
|---|---|---|
| Medical Files data extractionMedical Files data extraction | Other | Cardiac insufficiency |
Primary outcome
Direct failure rate of the mixed approach
Time frame: 7 years
Direct failure rate of the mixed approach
Demographic data
Time frame: 7 years
Demographic data (descriptive analysis)
Risks factors
Time frame: 7 years
Descriptive analysis of the risks factors linked to the failure of the procedure
Type of cardiopathy
Time frame: 7 years
Type of cardiopathy
PR interval
Time frame: 7 years
PR interval
QRS interval
Time frame: 7 years
QRS interval
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 May 2018.
- 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.
Pierre Wauthy, MD study director
CHU Brugmann
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 Cardiac Insufficiency, run by Pierre Wauthy at 1 site in Belgium.
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 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 31 May 2018. 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 Belgium. 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?
Direct failure rate of the mixed approach (time frame: 7 years). The study lists 6 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 31 May 2018.