NCT03083301

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

Completed Last updated 31 May 2018

What this trial tests

trial testing Medical Files data extraction in Cardiac Insufficiency in 155 participants. Completed in 29 May 2018.

Timeline

1 April 2017

Primary endpoint
29 May 2018

29 May 2018

Quick facts

Lead sponsor	Pierre Wauthy
Status	Completed
Study type	OBSERVATIONAL
Enrollment	155
Start date	1 April 2017
Primary completion	29 May 2018
Estimated completion	29 May 2018
Sites	1 location across Belgium

Drugs / interventions tested

• Medical Files data extraction

Conditions studied

• Cardiac Insufficiency — all drugs for Cardiac Insufficiency →

Sponsor

Pierre Wauthy

Who can join

18 and older, any sex, with Cardiac Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.