Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe
NCT ID: NCT03083301
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
155 participants
OBSERVATIONAL
2017-04-01
2018-05-29
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
Medical Files data extraction
Medical Files data extraction
Interventions
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Medical Files data extraction
Medical Files data extraction
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pierre Wauthy
OTHER
Responsible Party
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Pierre Wauthy
CHU Brugmann
Principal Investigators
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Pierre Wauthy, MD
Role: STUDY_DIRECTOR
CHU Brugmann
Locations
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CHU Brugmann
Brussels, , Belgium
Countries
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Other Identifiers
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CHUB-cardiac resynchronization
Identifier Type: -
Identifier Source: org_study_id