Bradycardia; Sick Sinus Syndrome, AV Block Clinical Trial
Official title:
IntAct, Study on Promotion of Intrinsic Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | April 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | A.ö. Krankenhaus der Elisabethinen Linz | Linz | |
| Czech Republic | Fakultni nemocnice u svate Anny v Berne | Brno | |
| Czech Republic | Fakulti Nemocnice, University Hospital of Brno-Bohunice | Brno- Bohunice | |
| Czech Republic | University Hospital with Polyclinics Ostrava | Ostrava | |
| Czech Republic | Nemocnice Na Homolce Hospital | Prague | |
| Czech Republic | Kardiologicka kllinika | Praha 10 | |
| Czech Republic | Masarykova Nemocnice | Usti nad Labem | |
| Denmark | Hillerod Sygehus | Hillerod | |
| Denmark | Vejle Sygehus | Vejle | |
| Finland | Tampere University Central Hospital | Tampere | |
| Finland | University of Oulu, Depart. of Internal Medicine, Div. of Cardiology | University of Oulu | |
| Germany | Elisabeth Krankenhaus | Essen | |
| Germany | Stadt. Klinikum Leverkussen | Leverkussen | |
| Germany | Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen | Munchen | |
| Germany | Stadtisches Klinikum Pforzheim | Pforazheim | |
| Germany | Kreiskrankenhaus Rottweil | Rottweil | |
| Germany | Universitätsklinikum Ulm | Ulm | |
| Italy | Arcispedale S. Maria Nuova | Reggio Emilia | Emilia Romagna |
| Italy | San Camillo De' Lellis | Rieti | |
| Netherlands | Meander Medisch Centrum, Lokatie Lichtenberg | Amersfoort | |
| Netherlands | St. Lucas Andreas Ziekenhuis | Amsterdam | |
| Netherlands | Bronovo Ziekenhuis | Den Haag | |
| Netherlands | Catharina Hospital | Eindhoven | |
| Russian Federation | Hospital Nr.: 26 | Saint-Petersburg | |
| Russian Federation | Pokrovskiy Hospital | Saint-Petersburg | |
| Sweden | Medicinkliniken | Boras | |
| Sweden | Karolinska University Hospital Hjartkliniken | Stockholm | |
| Switzerland | Kantonsspital Kardiologie | Basel | |
| Switzerland | Inselspital Bern, Schweizer Herz- und Gefasszentrum | Bern | |
| United Kingdom | Blackpool Victoria Hospital | Blackpool |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic BRC |
Austria, Czech Republic, Denmark, Finland, Germany, Italy, Netherlands, Russian Federation, Sweden, Switzerland, United Kingdom,
Andersen HR, Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Atrial verses dual chamber pacing in patients with sick sinus syndrome, atrial fibrillation, congestive heart failure and mortality during follow-up in a randomised trial of 177 patients. PACE 2001; 24: 575 Abstract 174
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Boute W, Brunekreeft W. AV delay hysteresis in dual chamber pacing: initial results from the Ruby Clinical Investigation. Vitatext 1994; 1: 13-14
Brandt J, Anderson H, Fåhraeus T, Schüller 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. — View Citation
Carisma MB, Manalo JM, Chua WT. Atrioventricular conduction in sick sinus syndrome. Pacing Clin Electrophysiol. 1988 Nov;11(11 Pt 2):1636-40. — View Citation
Charles RG, McComb JM. Systematic trial of pacing to prevent atrial fibrillation (STOP-AF). Heart. 1997 Sep;78(3):224-5. — View Citation
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. — View Citation
Cohen SI, Frank HA. Preservation of active atrial transport; an important clinical consideration in cardiac pacing. Chest. 1982 Jan;81(1):51-4. — View Citation
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. — View Citation
Connolly SJ, Talajic M, Roy D, Tang ASL, Lav C, Bonilla L, Gillis AM. The effect of pacemaker selection on functional capacity in the Canadian Trial of Physiologic Pacing (CTOPP). Circulation 1999; 100(suppl I): I-465
Danish pacemaker and ICD register. 1999. Pacing Clin Electrophysiol. 2000 Oct;23(10 Pt 2):S1-93. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kallryd A, Kruse I, Rydén 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. — View Citation
Kerr CR, Tyers GF, Vorderbrugge S. Atrial pacing: efficacy and safety. Pacing Clin Electrophysiol. 1989 Jul;12(7 Pt 1):1049-54. — View Citation
Kristensen L, Nielsen JC, Andersen HR. Outcome of patients with sick sinus syndrome treated by different pacing modalities. In Ovsyshcher IE (ed): Cardiac arrhythmias and device therapy results and perspectives for the new century. Futura Publishing Company Inc., Armonk NY, 2000, 323-332.
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; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Narula OS. Atrioventricular conduction defects in patients with sinus bradycardia. Analysis by His bundle recordings. Circulation. 1971 Dec;44(6):1096-110. — View Citation
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. — View Citation
Nielsen JC, Kristensen L, Pedersen AK, Mortensen PT, Pedersen OL. Changes in left atrial size and left ventricular size and functioning during follow-up of 177 patients with sick sinus syndrome randomised to atrial or dual chamber pacing. PACE 2001; 24: 697 Abstract 633
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. — View Citation
Prech M, Grygier M, Mitkowski P, Stanek K, Skorupski W, Moszyñska 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. — View Citation
Rosenqvist M, Bergfeldt L, Haga Y, Rydén J, Rydén L, Owall A. The effect of ventricular activation sequence on cardiac performance during pacing. Pacing Clin Electrophysiol. 1996 Sep;19(9):1279-86. — View Citation
Rosenqvist M, Brandt J, Schüller 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. — View Citation
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. — View Citation
Skanes AC, Krahn AD, Yee R, Klein GJ, Connolly SJ, Kerr CR, Gent M, Thorpe KE, Roberts RS; Canadian Trial of Physiologic Pacing. Progression to chronic atrial fibrillation after pacing: the Canadian Trial of Physiologic Pacing. CTOPP Investigators. J Am Coll Cardiol. 2001 Jul;38(1):167-72. — View Citation
Stangl K, Seitz K, Wirtzfeld A, Alt E, Blömer 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. — View Citation
Stierle U, Krüger 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. — View Citation
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. — View Citation
Sutton R, Kenny RA. The natural history of sick sinus syndrome. Pacing Clin Electrophysiol. 1986 Nov;9(6 Pt 2):1110-4. Review. — View Citation
The MOST Trial Investigators. Baseline QRS duration = 120 milliseconds and cumulative percent time ventricular paced predicts increased risk of heart failure, stroke and death in DDDR-paced patients with sick sinus syndrome in MOST. PACE 2002; 690 Abstract 672
The MOST Trial Investigators. Effect of pacing mode and cumulative percent time ventricular paced on heart failure in patients with sick sinus syndrome and baseline QRS duration < 120 milliseconds in MOST. PACE 2002; 561 Abstract 155.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Woodend K, Tang SI, Irvine J, Connolly S, Lav C, Paquette M, Newman D. Pacemaker dependency conditions the QOL benefits of physiologic over VVI pacing: Canadian Trial of Physiologic Pacing (CTOPP). Circulation 1999; 100(suppl I): I-20
* Note: There are 49 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization | |||
| Secondary | 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 | |||
| Secondary | Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization | |||
| Secondary | 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 | |||
| Secondary | Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF |