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

NCT03083301 | Completed

• 1 other identifier: CHUB-cardiac resynchronization
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Insufficiency

Keywords

Cardiac resynchronisation

Outcome Measures

Primary Outcomes (6)

• Direct failure rate of the mixed approach

  Direct failure rate of the mixed approach

  7 years

• Demographic data

  Demographic data (descriptive analysis)

  7 years

• Risks factors

  Descriptive analysis of the risks factors linked to the failure of the procedure

  7 years

• Type of cardiopathy

  Type of cardiopathy

  7 years

• PR interval

  PR interval

  7 years

• QRS interval

  QRS interval

  7 years

Study Arms (1)

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

Other: Medical Files data extraction

Interventions

Medical Files data extraction OTHER

Medical Files data extraction

Cardiac insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pierre Wauthy, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CHU Brugmann

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 20, 2017
• Study Start: April 1, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)