Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients

Phase 4

Completed

• Conditions: Cardiac Pacing, Artificial

• Registration Number: NCT00323661
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.

Detailed Description

Within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. Accelerometer sensor will be compared with Closed Loop Stimulation over 2 years. The cognitive performance will be measured by means of a standardized psychometric test. The occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. An analysis of the telemonitored (Home Monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-09
• Primary Completion: 2010-11
• Study Completion: 2011-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks)
• Closed Loop Stimulation mode activated since pre-hospital discharge
• Patients with chronotropic incompetence according to physician's judgment
• Maximum sinus rate < 100 beats per minute (bpm) OR percentage of atrial pacing ≥ 25%
• Patients suitable for rate-adaptive pacing for at least 2 years
• Patient informed consent

Exclusion Criteria

• Age under 55
• Pregnant and breast-feeding women
• Patients who are already enrolled in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive performance assessed by the Number Connection Test	24 months

Secondary Outcome Measures

Name	Time	Method
self-assessment of general well-being, mental and physical performance assessed by Visual Analogue Scales	12 months and 24 months
Home Monitoring data	24 months
Quality of life assessed by the SF-08	12 months and 24 months
occurrence of atrial fibrillation	12 months and 24 months
occurrence of serious adverse events	12 months and 24 months

Trial Locations

Locations (55)

Marien-Hospital Erftstadt-Frauenthal; 🇩🇪 Erftstadt-Frauenthal, Germany

Hospital Sao Francisco; 🇧🇷 Porto Alegre, Brazil

Nemocnica Ministerstva Obrany; 🇸🇰 Bratislava, Slovakia

Wolfson Medical Center; 🇮🇱 Holon, Israel

Hospital Universitario La Fé; 🇪🇸 Valencia, Spain

Sydney Adventist Hospital; 🇦🇺 Sydney, Australia

A.ö. Krankenhaus der Stadt Linz; 🇦🇹 Linz, Austria

Krankenhaus der Barmherzigen Schwestern Ried; 🇦🇹 Ried, Austria

A. ö. Landeskrankenhaus Steyr; 🇦🇹 Steyr, Austria

Wilhelminenspital der Stadt Wien; 🇦🇹 Wien, Austria

Hospital Anchieta, Instituto do Coracao de Taguatinga; 🇧🇷 Brasilia - DF, Brazil

Practice Dr. Bloomberg; 🇨🇦 Burnaby, B.C., Canada

Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia; 🇧🇷 Sao Paulo, Brazil

Kelowna Cardiology Research; 🇨🇦 Kelowna BC, Canada

Dr. Dante Manyauri; 🇨🇦 Surrey BC, Canada

Hopital Sacre-Coeur; 🇨🇦 Montreal, Canada

Scarborough Cardiology Research; 🇨🇦 Toronto, Ontario, Canada

Universitätsklinik der RWTH Aachen; 🇩🇪 Aachen, Germany

Fakultni Nemocnice u Svety Anny; 🇨🇿 Brno, Czech Republic

St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie; 🇩🇪 Bocholt, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Klinikum Lippe-Detmold; 🇩🇪 Detmold, Germany

Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Kreisklinik Ebersberg GmbH; 🇩🇪 Ebersberg, Germany

Klinken Erlabrunn GmbH; 🇩🇪 Erlabrunn, Germany

Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen; 🇩🇪 Essen, Germany

Kardiologisches Zentrum am Zoo; 🇩🇪 Frankfurt, Germany

St. Elisabeth-Hospital; 🇩🇪 Gütersloh, Germany

Klinikum der Medizinischen Fakultät Halle-Wittenberg; 🇩🇪 Halle, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

AK Altona; 🇩🇪 Hamburg, Germany

St. Vinzenz-Krankenhaus Hanau gGmbH; 🇩🇪 Hanau, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Herford; 🇩🇪 Herford, Germany

Klinikum der Universität Jena Klinik für Innere Medizin I; 🇩🇪 Jena, Germany

Evangelisches Krankenhaus Holzminden; 🇩🇪 Holzminden, Germany

Kardiologische Gemeinschaftspraxis; 🇩🇪 Kiel, Germany

Städtisches Klinikum St. Georg; 🇩🇪 Leipzig, Germany

Universitätsklinikum Lübeck; 🇩🇪 Lübeck, Germany

Krankenhaus St. Franziskus, Medizinische Klinik II; 🇩🇪 Mönchengladbach, Germany

St. Vincenz-Krankenhaus GmbH; 🇩🇪 Paderborn, Germany

Kardiologische Praxis; 🇩🇪 Papenburg, Germany

Christl. Krankenhaus Quakenbrück; 🇩🇪 Quakenbrück, Germany

St. Adolf-Stift; 🇩🇪 Reinbek, Germany

Elisabeth Krankenhaus GmbH; 🇩🇪 Recklinghausen, Germany

Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert; 🇩🇪 Riesa, Germany

Evangelisches Elisabeth Krankenhaus; 🇩🇪 Trier, Germany

Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat; 🇩🇪 Viersen, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Princess Margaret Hospital; 🇭🇰 Hong Kong, Hong Kong

Yan Chai Hospital; 🇭🇰 Hong Kong, Hong Kong

Städtische Kliniken Bielefeld, Klinikum Mitte; 🇩🇪 Bielefeld, Germany

VUSCH East Slovak Cardiology Institute, Arytmology; 🇸🇰 Kosice, Slovakia

Zentrum für Kardiologische und Angiologische Medizin Hamburg; 🇩🇪 Hamburg, Germany