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Clinical Trial: Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
This study is currently recruiting patients.
Verified by Vitatron B.V. September 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Bradycardia; sick sinus syndrome, AV Block | Device: Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 Procedure: Required pacemaker setting | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: IntAct, Study on Promotion of Intrinsic Activity.
Secondary Outcomes: Occurrence of possible undesired consequences of the RVP algorithm (e.g. retrograde conduction; AF burden) and adverse events in the periods with the algorithm switched ON versus OFF, 4 and 8 weeks after randomization; Patient’s opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization; explorative subanalysis on patients with different arrhythmias and/or conducting system defects to investigate in which type of patients the RVP algorithm will have the largest impact on %VP; Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF
Expected Total Enrollment: 150
Study start: April 2004; Expected completion: September 2006
Last follow-up: April 2006
Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accumulating that ventricular pacing may also have undesired long-term cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce ventricular pacing.
After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed according to predefined settings.
In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on these data, patients will be excluded from further participation (patients with more than 15% atrial fibrillation) or subdivided into three groups: (a) < 30% VP (30- VP group), (b) >30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) >30% VP, 1st or 2nd degree AV block. Patients in these three groups will be treated for 4 weeks alternatively with the RVP functionality switched ON or OFF. The order will be determined by randomization. At the end of these two cross-over periods the % VP and the judgment of the patients of the last period will be assessed. Adverse events will be recorded from the moment of study enrolment.
Eligibility
Inclusion Criteria:
- Patients shall be willing to sign the Patient Informed Consent for this study
- Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
- First degree AV block with a PR interval <_220 ms for patients <_ 70 years of age, or <_ 260 for patients over 70 years
- Second-degree AV block, mobitz I (wenckebach) or mobitz II
- Patients shall be available for follow-up for the duration of their participation.
Exclusion Criteria:
- Patients involved in another investigation study conducted in parallel to this study
- Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
- Pregnant patients
- Patients with lead integrity problems (and the lead is not being replaced)
- Patients with persistant AF
- Patients with a complete AV block
- Patients with NYHA (New York Heart Association0 class III and IV
- Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
- Patients with a 2:1 block
- Patients with a life expectancy less than half a year
Location and Contact Information
Joyce Kleinhuis - Coldewijn +31 263767452 joyce.kleinhuis-coldewijn@vitatron.com
Austria
A.ö. Krankenhaus der Elisabethinen Linz, Linz, 4010, Austria; Recruiting
S. Winter, MD, Principal Investigator
Czech Republic
Nemocnice Na Homolce Hospital, Prague, 150 30, Czech Republic; Recruiting
M. Taborsky, MUDr, Principal Investigator
University Hospital with Polyclinics Ostrava, Ostrava, 708 50, Czech Republic; Recruiting
T. Minarik, MUDr., Principal Investigator
Masarykova Nemocnice, Usti nad Labem, 40113, Czech Republic; Recruiting
J. Nebaznivy, MUDr, Principal Investigator
Fakulti Nemocnice, University Hospital of Brno-Bohunice, Brno-Bohunice, 639 00, Czech Republic; Recruiting
J. Spinar, MUDr, Principal Investigator
Kardiologicka kllinika, Praha 10, 100 34, Czech Republic; Recruiting
M. Herold, MUDr, Principal Investigator
Fakultni nemocnice u svate Anny v Berne, Brno, 656 91, Czech Republic; Recruiting
M. Novak, MUDr., Principal Investigator
Denmark
Hillerod Sygehus, Hillerod, 3400, Denmark; Recruiting
E.H. Simonsen, MD, Principal Investigator
Vejle Sygehus, VEJLE, 7100, Denmark; Recruiting
Eriksen, MD, Principal Investigator
Finland
Tampere University Central Hospital, Tampere, 33521, Finland; Recruiting
V. Virtanen, MD, Principal Investigator
University of Oulu, Depart. of Internal Medicine, Div. of Cardiology, University of Oulu, 9000 14, Finland; Recruiting
P. Raatikainen, MD, Principal Investigator
Germany
Universitätsklinikum Ulm, Ulm, 89081, Germany; Recruiting
L. Binner, MD, Principal Investigator
Stadt. Klinikum Leverkussen, Leverkussen, 51375, Germany; Recruiting
B. Weidmann, MD, Principal Investigator
Stadtisches Klinikum Pforzheim, Pforazheim, 75175, Germany; No longer recruiting
Kreiskrankenhaus Rottweil, Rottweil, 78628, Germany; Recruiting
W. Steffen, MD, Principal Investigator
Elisabeth Krankenhaus, ESSEN, 45138, Germany; Recruiting
M. Meine, MD, Principal Investigator
Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen, Munchen, 80636, Germany; Recruiting
C. Kolb, Dr. med., Principal Investigator
Italy
San Camillo De'''' Lellis, Rieti, 02100, Italy; Recruiting
S. Orazi, MD, Principal Investigator
Italy, Emilia Romagna
Arcispedale S. Maria Nuova, Reggio Emilia, Emilia Romagna, 42100, Italy; Recruiting
Carlos Menozzi, MD, Principal Investigator
Netherlands
Bronovo Ziekenhuis, Den Haag, 2597 AX, Netherlands; Recruiting
M.I. Sedney, MD, Principal Investigator
St. Lucas Andreas Ziekenhuis, Amsterdam, 1061 AE, Netherlands; Recruiting
J. Visser, MD, Principal Investigator
Catharina Hospital, Eindhoven, 5623 EJ, Netherlands; No longer recruiting
Meander Medisch Centrum, Lokatie Lichtenberg, Amersfoort, 3818 ES, Netherlands; Recruiting
S. Senden, MD, Principal Investigator
Russian Federation
Hospital Nr.: 26, Saint Petersburg, 199106, Russian Federation; Recruiting
S. Yuzvinkevich, MD, Principal Investigator
Pokrovskiy Hospital, Saint Petersburg, 199106, Russian Federation; Recruiting
T. Novikova, MD, Principal Investigator
Sweden
Karolinska University Hospital Hjartkliniken, Stockholm, 141 86, Sweden; Recruiting
P. Lindell, MD, Principal Investigator
Medicinkliniken, Boras, 501 82, Sweden; Recruiting
S. Sandgren, MD, Principal Investigator
Switzerland
Inselspital Bern, Schweizer Herz- und Gefasszentrum, Bern, 3010, Switzerland; Recruiting
E. Delacretaz, Prof. Dr., Principal Investigator
Kantonsspital Kardiologie, Basel, 4031, Switzerland; Recruiting
S. Osswald, Prof. Dr., Principal Investigator
United Kingdom
Blackpool Victoria Hospital, Blackpool, FY3 8NR, United Kingdom; No longer recruiting
Ludwig Binner, MD, Study Chair, Universitätsklinikum Ulm, Ulm, Germany
Chris van Groeningen, MD, Study Director, Vitatron B.V., Arnhem, The Netherlands
More Information
Publications
Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91.
Gillis AM, Goldman BS, Yee R, Irwin ME, Wilson SL, Ashton T, Philippon F, Fraser JD, Clavette P, Tyers GF. Cardiac pacing in Canada in 1998: working towards optimal pacing therapy. Canadian Working Group on Cardiac Pacing. Can J Cardiol. 1998 Sep;14(9):1115-20.
Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104.
[No authors listed] Danish pacemaker and ICD register. 1999. Pacing Clin Electrophysiol. 2000 Oct;23(10 Pt 2):S1-93. No abstract available.
Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.
Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62.
[No authors listed] Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. N Engl J Med. 1991 Feb 7;324(6):424-8. No abstract available.
Andersen HR, Thuesen L, Bagger JP, Vesterlund T, Thomsen PE. Prospective randomised trial of atrial versus ventricular pacing in sick-sinus syndrome. Lancet. 1994 Dec 3;344(8936):1523-8.
Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.
Barold SS. Indications for permanent cardiac pacing in first-degree AV block: class I, II, or III? Pacing Clin Electrophysiol. 1996 May;19(5):747-51. No abstract available.
Bode F, Wiegand U, Katus HA, Potratz J. Inhibition of ventricular stimulation in patients with dual chamber pacemakers and prolonged AV conduction. Pacing Clin Electrophysiol. 1999 Oct;22(10):1425-31.
Brandt J, Anderson H, Fahraeus T, Schuller H. Natural history of sinus node disease treated with atrial pacing in 213 patients: implications for selection of stimulation mode. J Am Coll Cardiol. 1992 Sep;20(3):633-9.
Carisma MB, Manalo JM, Chua WT. Atrioventricular conduction in sick sinus syndrome. Pacing Clin Electrophysiol. 1988 Nov;11(11 Pt 2):1636-40.
Charles RG, McComb JM. Systematic trial of pacing to prevent atrial fibrillation (STOP-AF). Heart. 1997 Sep;78(3):224-5. No abstract available.
Cohen SI, Frank HA. Preservation of active atrial transport; an important clinical consideration in cardiac pacing. Chest. 1982 Jan;81(1):51-4.
Clarke KW, Connelly DT, Charles RG. Single chamber atrial pacing: an underused and cost-effective pacing modality in sinus node disease. Heart. 1998 Oct;80(4):387-9.
Elshot SR, el Gamal MI, Tielen KH, van Gelder BM. Incidence of atrioventricular block and chronic atrial flutter/fibrillation after implantation of atrial pacemakers; follow-up of more than ten years. Int J Cardiol. 1993 Mar;38(3):303-8.
Grimm W, Langenfeld H, Maisch B, Kochsiek K. Symptoms, cardiovascular risk profile and spontaneous ECG in paced patients: a five-year follow-up study. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2086-90.
Harper GR, Pina IL, Kutalek SP. Intrinsic conduction maximizes cardiopulmonary performance in patients with dual chamber pacemakers. Pacing Clin Electrophysiol. 1991 Nov;14(11 Pt 2):1787-91.
Haywood GA, Ward J, Ward DE, Camm AJ. Atrioventricular Wenckebach point and progression to atrioventricular block in sinoatrial disease. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2054-8.
Hesselson AB, Parsonnet V, Bernstein AD, Bonavita GJ. Deleterious effects of long-term single-chamber ventricular pacing in patients with sick sinus syndrome: the hidden benefits of dual-chamber pacing. J Am Coll Cardiol. 1992 Jun;19(7):1542-9. Review.
Jutzy RV, Feenstra L, Pai R, Florio J, Bansal R, Aybar R, Levine PA. Comparison of intrinsic versus paced ventricular function. Pacing Clin Electrophysiol. 1992 Nov;15(11 Pt 2):1919-22.
Kallryd A, Kruse I, Ryden L. Atrial inhibited pacing in the sick sinus node syndrome: clinical value and the demand for rate responsiveness. Pacing Clin Electrophysiol. 1989 Jun;12(6):954-61.
Kerr CR, Tyers GF, Vorderbrugge S. Atrial pacing: efficacy and safety. Pacing Clin Electrophysiol. 1989 Jul;12(7 Pt 1):1049-54.
Leclercq C, Gras D, Le Helloco A, Nicol L, Mabo P, Daubert C. Hemodynamic importance of preserving the normal sequence of ventricular activation in permanent cardiac pacing. Am Heart J. 1995 Jun;129(6):1133-41.
Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6.
Montanez A, Hennekens CH, Zebede J, Lamas GA. Pacemaker mode selection: the evidence from randomized trials. Pacing Clin Electrophysiol. 2003 May;26(5):1270-82. Review.
Narula OS. Atrioventricular conduction defects in patients with sinus bradycardia. Analysis by His bundle recordings. Circulation. 1971 Dec;44(6):1096-110. No abstract available.
Nielsen JC, Pedersen AK, Mortensen PT, Andersen HR. Programming a fixed long atrioventricular delay is not effective in preventing ventricular pacing in patients with sick sinus syndrome. Europace. 1999 Apr;1(2):113-20.
Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23.
Prech M, Grygier M, Mitkowski P, Stanek K, Skorupski W, Moszynska B, Zerbe F, Cieslinski A. Effect of restoration of AV synchrony on stroke volume, exercise capacity, and quality-of-life: can we predict the beneficial effect of a pacemaker upgrade? Pacing Clin Electrophysiol. 2001 Mar;24(3):302-7.
Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22.
Rosenqvist M, Bergfeldt L, Haga Y, Ryden J, Ryden L, Owall A. The effect of ventricular activation sequence on cardiac performance during pacing. Pacing Clin Electrophysiol. 1996 Sep;19(9):1279-86.
Santini M, Alexidou G, Ansalone G, Cacciatore G, Cini R, Turitto G. Relation of prognosis in sick sinus syndrome to age, conduction defects and modes of permanent cardiac pacing. Am J Cardiol. 1990 Mar 15;65(11):729-35.
Stangl K, Seitz K, Wirtzfeld A, Alt E, Blomer H. Differences between atrial single chamber pacing (AAI) and ventricular single chamber pacing (VVI) with respect to prognosis and antiarrhythmic effect in patients with sick sinus syndrome. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2080-5.
Stierle U, Kruger D, Vincent AM, Mitusch R, Giannitsis E, Wiegand U, Potratz J. An optimized AV delay algorithm for patients with intermittent atrioventricular conduction. Pacing Clin Electrophysiol. 1998 May;21(5):1035-43.
Sulke N, Chambers J, Dritsas A, Sowton E. A randomized double-blind crossover comparison of four rate-responsive pacing modes. J Am Coll Cardiol. 1991 Mar 1;17(3):696-706.
Sutton R, Kenny RA. The natural history of sick sinus syndrome. Pacing Clin Electrophysiol. 1986 Nov;9(6 Pt 2):1110-4. Review.
Toff WD, Skehan JD, De Bono DP, Camm AJ. The United Kingdom pacing and cardiovascular events (UKPACE) trial. United Kingdom Pacing and Cardiovascular Events. Heart. 1997 Sep;78(3):221-3. No abstract available.
Vardas PE, Simantirakis EN, Parthenakis FI, Chrysostomakis SI, Skalidis EI, Zuridakis EG. AAIR versus DDDR pacing in patients with impaired sinus node chronotropy: an echocardiographic and cardiopulmonary study. Pacing Clin Electrophysiol. 1997 Jul;20(7):1762-8.
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00156741
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13
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