Cardiac Resynchronization Therapy in Congenital Heart Defects

Phase 2

Completed

• Conditions: Congenital Heart Defects
• Interventions: Device: Implantation and testing of CRT

• Registration Number: NCT00450684
• Lead Sponsor: Competence Network for Congenital Heart Defects

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-21
• Study First Submitted QC: 2007-03-21
• Study First Posted: 2007-03-22
• Study Start: 2007-05
• Primary Completion: 2012-02
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patients with congenital heart defects
• Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of < 40% in the failed ventricle
• NYHA classes II-IV
• Optimal drug therapy for heart failure according to the ESC guidelines
• QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
• Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
• Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above

Exclusion Criteria

• PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
• Patients with pulmonary hypertension / Eisenmenger's syndrome
• Life expectancy < 1 year due to a non-cardiac disease
• Anticipated poor compliance by the patient
• Pregnancy and breastfeeding
• Known or persistent abuse of prescription medicines, recreational drugs or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Implantation and testing of CRT	Implantation and testing of CRT
Group B	Implantation and testing of CRT	IImplantation and testing of CRT

Primary Outcome Measures

Name	Time	Method
Ejection fraction	7 visits
QRS-interval	7 visits

Secondary Outcome Measures

Name	Time	Method
Spiroergometry: performance P (W/kg), incl. VO2,max	6 visits
Decrease of hospitalization	18 months
Walking distance in 6 minutes	6 visits
NT pro-BNP	7 visits
Quality of life	6 visits
death	18 months
Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)	7 visits
Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function	7 visits
3D echocardiography:LV volumes, LVEF, Dyssynchrony index	7 visits
Decrease of ventricular and atrial arrhythmias	18 months
Prevention or postponement of heart transplantation	18 Months

Trial Locations

Locations (16)

Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie; 🇩🇪 Bremen, Germany

Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler; 🇩🇪 Sankt Augustin, Germany

Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie; 🇩🇪 Berlin, Germany

Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie; 🇩🇪 Homburg/Saar, Germany

Universitäres Herzzentrum Hamburg, Kinderkardiologie; 🇩🇪 Hamburg, Germany

Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler; 🇩🇪 Bad Oeynhausen, Germany

Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie; 🇩🇪 Münster, Germany

Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin; 🇩🇪 Tübingen, Germany

Universitätsklinikum Erlangen, Kinderkardiologische Abteilung; 🇩🇪 Erlangen, Germany

Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie; 🇩🇪 Aachen, Germany

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie; 🇩🇪 Halle, Saxony-Anhalt, Germany

Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie; 🇩🇪 Berlin, Germany

Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler; 🇩🇪 München, Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie; 🇩🇪 Freiburg, Germany

Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler; 🇩🇪 Münster, North Rhine-Westphalia, Germany

AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie; 🇦🇹 Wien, Austria