Right ventricular apical pacing in patients treated with a pacemaker is unnessessary in cases where patients have stable AV-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search-AV + algorithm was designed to avoid ventricular pacing and support entrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. Goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV + algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.

Condition	Intervention	Phase
Sinus Node Disease	Device: Search AV + - algorithm	Phase IV

Further Study Details: 

Primary Outcomes: Amount of right ventricular pacing
Secondary Outcomes: Change in intrinsic AV-delay; Hospitalizations because of symptomatic heart failure; Hospitalizations because of symptomatic atrial fibrillation; Medication
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients with sinus node disease and an intrinsic AV-delay of maximal 260 ms Patients treated with a Medtronic pacamaker with AV search + -Algorithm

Exclusion Criteria:

Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction NYHA III / IV Instable angina pectoris Heart valve vitium Persistent AV-block II and III Early diastolic mitral regurgitation Implantable Cardioverter Defibrillator Participation on other clinical studies Pregnancy or unreliable birth control AV-block under strain

Please refer to this study by ClinicalTrials.gov identifier  NCT00157794

Michael Jakob, MD      0689766280    jakob @KKSulzbach.de
Peter Lamm, MD      089 7095 3459    lamm@hch.med.uni-muenchen.de

Germany
      Knappschaftskrankenhaus Sulzbach, Medizinische Klinik, Sulzbach,  66280,  Germany; Recruiting
      St. Vincentius Kliniken, Karlsruhe,  76135,  Germany; Recruiting
      Josephs-Hospital, Warendorf,  48231,  Germany; Recruiting
      Internistische Praxis Dr. med. Schade, Berlin,  13187,  Germany; Recruiting
      Kreiskrankenhaus Ottweiler, Ottweiler,  66564,  Germany; Recruiting
      Klinikum der Johannes-Gutenberg-Universität, Mainz,  55131,  Germany; Recruiting
      St. Josefs Hospital, Bochum,  44791,  Germany; Recruiting
      Praxis Dr. med. Markert, Gaggenau,  76571,  Germany; Recruiting
      Vinzentius Krankenhaus, Landau,  76829,  Germany; Recruiting
      Städtisches Klinikum Neunkirchen, Neunkirchen,  66538,  Germany; Recruiting
      Universitätsklinikum Heidelberg, Heidelberg,  69120,  Germany; Recruiting
      Krankenhaus Martha Maria Halle, Halle,  Germany; Recruiting
      Gemeinschaftspraxis Dr. Tamm / Dr. Hon, Wittenberg,  Germany; Recruiting
Germany, Bavaria
      Klinikum Großhadern Herzchirurgische Klinik und Poliklinik, Munich,  Bavaria,  81377,  Germany; Recruiting

Study chairs or principal investigators

Michael Jakob, MD,  Principal Investigator,  Knappschaftskrankenhaus Sulzbach   
Peter Lamm, MD,  Principal Investigator,  Klinikum der Universität München Großhadern   

Study ID Numbers:  CEN_G_CA_2
Last Updated:  September 10, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00157794
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13