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Completed

NCT Number: NCT03083301

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

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.

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Key information

Conditions

Cardiac Insufficiency Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Files data extraction

Other

Medical Files data extraction

Primary outcomes

  1. Direct failure rate of the mixed approach

    Time frame: 7 years

    Direct failure rate of the mixed approach

  2. Demographic data

    Time frame: 7 years

    Demographic data (descriptive analysis)

  3. Risks factors

    Time frame: 7 years

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

  4. Type of cardiopathy

    Time frame: 7 years

    Type of cardiopathy

  5. PR interval

    Time frame: 7 years

    PR interval

  6. QRS interval

    Time frame: 7 years

    QRS interval

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2017
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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