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

NCT00323661 | Completed Phase 4

• 1 other identifier: BA079
• Study Type: interventional
• Target: 405
• Locations: 9 countries
• Sites: 51

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.

Conditions

Cardiac Pacing, Artificial

Keywords

Pacing; Rate-adaptive; Quality of life; Cognitive performance; Atrial fibrillation; Pacemaker sensor

Outcome Measures

Primary Outcomes (1)

• Cognitive performance assessed by the Number Connection Test

  24 months

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Rate-adaptation by Closed Loop Stimulation

Device: Rate-adaptive pacemaker: Closed Loop Stimulation

2

ACTIVE COMPARATOR

Accelerometer based pacing rate adaptation

Device: Rate-adaptive pacemaker: accelerometer

Interventions

Rate-adaptive pacemaker: accelerometer DEVICE

Accelerometer based pacing rate adaptation

2

Rate-adaptive pacemaker: Closed Loop Stimulation DEVICE

Closed Loop Stimulation (CLS) is a unique concept in rate-adaptive pacing that uses the natural cardiovascular control loop to determine the appropriate pacing rate. Closed Loop Stimulation is the only rate-adaptive system responding to mental stress and thereby assuring optimal cerebral perfusion in everyday activity.

1

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (55)

Sydney Adventist Hospital

Sydney, NSW 2076, Australia

Location

A.ö. Krankenhaus der Stadt Linz

Linz, 4020, Austria

Location

Krankenhaus der Barmherzigen Schwestern Ried

Ried, 4910, Austria

Location

A. ö. Landeskrankenhaus Steyr

Steyr, 4400, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Hospital Anchieta, Instituto do Coracao de Taguatinga

Brasilia - DF, 71525-255, Brazil

Location

Hospital Sao Francisco

Porto Alegre, 90510-000, Brazil

Location

Hospital Real e Benemerita Sociedade Portuguesa de Beneficencia

São Paulo, 01323-001, Brazil

Location

Practice Dr. Bloomberg

Burnaby, B.C., V5H 2E3, Canada

Location

Kelowna Cardiology Research

Kelowna BC, V1Y 1E4, Canada

Location

Hopital Sacre-Coeur

Montreal, H4J 1C5, Canada

Location

Dr. Dante Manyauri

Surrey BC, V3V 1N1, Canada

Location

Scarborough Cardiology Research

Toronto, Ontario, M1P 2T7, Canada

Location

Fakultni Nemocnice u Svety Anny

Brno, 65691, Czechia

Location

Universitätsklinik der RWTH Aachen

Aachen, 52074, Germany

Location

Städtische Kliniken Bielefeld, Klinikum Mitte

Bielefeld, 33604, Germany

Location

St. Agnes Hospital GmbH, 1. Medizinische Klinik-Kardiologie

Bocholt, 46397, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Klinikum Lippe-Detmold

Detmold, 32756, Germany

Location

Med. Klinik/Kardiologie, Herzzentrum, Universitätsklinik an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Kreisklinik Ebersberg GmbH

Ebersberg, 85560, Germany

Location

Marien-Hospital Erftstadt-Frauenthal

Erftstadt-Frauenthal, 50374, Germany

Location

Klinken Erlabrunn GmbH

Erlabrunn, 08349, Germany

Location

Westdeutsches Herzzentrum Essen; Klinik für Kardiologie und Thorax-Kardiovaskuläre Chirurgie des Universitätsklinikums Essen

Essen, 45122, Germany

Location

Kardiologisches Zentrum am Zoo

Frankfurt, 60316, Germany

Location

St. Elisabeth-Hospital

Gütersloh, 33276, Germany

Location

Klinikum der Medizinischen Fakultät Halle-Wittenberg

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Zentrum für Kardiologische und Angiologische Medizin Hamburg

Hamburg, 22041, Germany

Location

AK Altona

Hamburg, 22763, Germany

Location

St. Vinzenz-Krankenhaus Hanau gGmbH

Hanau, 63450, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum Herford

Herford, 32049, Germany

Location

Evangelisches Krankenhaus Holzminden

Holzminden, 37603, Germany

Location

Klinikum der Universität Jena Klinik für Innere Medizin I

Jena, 07743, Germany

Location

Kardiologische Gemeinschaftspraxis

Kiel, 24116, Germany

Location

Städtisches Klinikum St. Georg

Leipzig, 04129, Germany

Location

Universitätsklinikum Lübeck

Lübeck, 23538, Germany

Location

Krankenhaus St. Franziskus, Medizinische Klinik II

Mönchengladbach, 41063, Germany

Location

St. Vincenz-Krankenhaus GmbH

Paderborn, 33098, Germany

Location

Kardiologische Praxis

Papenburg, 26871, Germany

Location

Christl. Krankenhaus Quakenbrück

Quakenbrück, 49610, Germany

Location

Elisabeth Krankenhaus GmbH

Recklinghausen, 45661, Germany

Location

St. Adolf-Stift

Reinbek, 21465, Germany

Location

Gemeinschaftspraxis Dr. Stenzel/Dr. Ebert

Riesa, 01587, Germany

Location

Evangelisches Elisabeth Krankenhaus

Trier, 54292, Germany

Location

Gemeinschaftspraxis Drs. Schley, Burkhard-Meier, Schemeitat

Viersen, 41747, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Yan Chai Hospital

Hong Kong, Hong Kong

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Nemocnica Ministerstva Obrany

Bratislava, 83331, Slovakia

Location

VUSCH East Slovak Cardiology Institute, Arytmology

Košice, 04011, Slovakia

Location

Hospital Universitario La Fé

Valencia, E-46009, Spain

Location

Related Publications (1)

• Wiegand U, Nuernberg M, Maier SK, Weiss C, Sancho-Tello MJ, Hartmann A, Schuchert A, Maier P, Chan NY. The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients. Pacing Clin Electrophysiol. 2008 Jun;31(6):709-13. doi: 10.1111/j.1540-8159.2008.01075.x.

  PMID: 18507543 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Uwe Wiegand, Prof. Dr.

  Sana-Klinikum Remscheid, 42859 Remscheid, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 9, 2006
• Study Start: May 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

CA (5); AU (1); SL (2); HK (2); IL (1); DE (35); CZ (1); BR (3); ES (1)