Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).
The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).
55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Implantation and testing of CRT |
|
| Group B | Experimental | IImplantation and testing of CRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation and testing of CRT | Device | Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON). |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction | 7 visits | |
| QRS-interval | 7 visits |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd) | 7 visits | |
| Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function | 7 visits | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hashim Abdul-Khaliq, Prof., MD | Competence Network for Congenital Heart Defects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie | Vienna | A-1090 | Austria | |||
| Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Implantation and testing of CRT | Device | Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON). |
|
| 3D echocardiography:LV volumes, LVEF, Dyssynchrony index |
| 7 visits |
| NT pro-BNP | 7 visits |
| Spiroergometry: performance P (W/kg), incl. VO2,max | 6 visits |
| Walking distance in 6 minutes | 6 visits |
| Decrease of hospitalization | 18 months |
| Decrease of ventricular and atrial arrhythmias | 18 months |
| Prevention or postponement of heart transplantation | 18 Months |
| Quality of life | 6 visits |
| death | 18 months |
| Münster |
| North Rhine-Westphalia |
| D-48149 |
| Germany |
| Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie | Halle | Saxony-Anhalt | D-06120 | Germany |
| Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie | Aachen | D-52074 | Germany |
| Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler | Bad Oeynhausen | D-32545 | Germany |
| Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie | Berlin | D-13353 | Germany |
| Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie | Berlin | D-13353 | Germany |
| Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie | Bremen | D-28227 | Germany |
| Universitätsklinikum Erlangen, Kinderkardiologische Abteilung | Erlangen | D-91054 | Germany |
| Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie | Freiburg im Breisgau | D-79106 | Germany |
| Universitäres Herzzentrum Hamburg, Kinderkardiologie | Hamburg | D-20246 | Germany |
| Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie | Homburg/Saar | D-66421 | Germany |
| Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler | München | D-80336 | Germany |
| Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie | Münster | D-48149 | Germany |
| Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler | Sankt Augustin | D-53757 | Germany |
| Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin | Tübingen | D-72076 | Germany |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided