Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe

Cardiac Insufficiency Clinical Trial

Official title:

Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083301
• Other study ID #: CHUB-cardiac resynchronization
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: May 29, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Change of case on a patient who has already benefited from a triple chamber stimulator

Related Conditions & MeSH terms

• Cardiac Insufficiency
• Heart Failure

Intervention

Other:
• Medical Files data extraction
Medical Files data extraction

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct failure rate of the mixed approach	Direct failure rate of the mixed approach	7 years
Primary	Demographic data	Demographic data (descriptive analysis)	7 years
Primary	Risks factors	Descriptive analysis of the risks factors linked to the failure of the procedure	7 years
Primary	Type of cardiopathy	Type of cardiopathy	7 years
Primary	PR interval	PR interval	7 years
Primary	QRS interval	QRS interval	7 years