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Bradycardia; Sick Sinus Syndrome, AV BlockPhase 4NCT00156741

Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.

A Phase 4 study testing Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 and Required pacemaker setting in people with Bradycardia; Sick Sinus Syndrome, AV Block, run by Medtronic BRC at 30 sites in 11 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 and Required pacemaker setting
How many people
150 participants
Where
30 sitesin 11 countries
Study dates
Apr 2004to Apr 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

30 sites in 11 countries.

30 sites in 11 countries

Czechia6 sites

  • Fakultni nemocnice u svate Anny v Berne

    Brno, 656 91

  • Fakulti Nemocnice, University Hospital of Brno-Bohunice

    Brno-Bohunice, 639 00

  • University Hospital with Polyclinics Ostrava

    Ostrava, 708 50

  • Kardiologicka kllinika

    Prague, 100 34

  • Nemocnice Na Homolce Hospital

    Prague, 150 30

  • Masarykova Nemocnice

    Ústí nad Labem, 40113

Other trials in Czechia

Germany6 sites

  • Elisabeth Krankenhaus

    Essen, 45138

  • Stadt. Klinikum Leverkussen

    Leverkussen, 51375

  • Deutschen Herzzentrum Munchen des Freistaates Bayern Klinik an der TU Munchen

    München, 80636

  • Stadtisches Klinikum Pforzheim

    Pforazheim, 75175

  • Kreiskrankenhaus Rottweil

    Rottweil, 78628

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Netherlands4 sites

  • Meander Medisch Centrum, Lokatie Lichtenberg

    Amersfoort, 3818 ES

  • St. Lucas Andreas Ziekenhuis

    Amsterdam, 1061 AE

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Bronovo Ziekenhuis

    The Hague, 2597 AX

Other trials in Netherlands

Denmark2 sites

  • Hillerod Sygehus

    Hillerød, 3400

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Finland2 sites

  • Tampere University Central Hospital

    Tampere, 33521

  • University of Oulu, Depart. of Internal Medicine, Div. of Cardiology

    University of Oulu, 9000 14

Other trials in Finland

Italy2 sites

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100

  • San Camillo De' Lellis

    Rieti, 02100

Other trials in Italy

Russia2 sites

  • Hospital Nr.: 26

    Saint Petersburg, 199106

  • Pokrovskiy Hospital

    Saint Petersburg, 199106

Other trials in Russia

Sweden2 sites

  • Medicinkliniken

    Borås, 501 82

  • Karolinska University Hospital Hjartkliniken

    Stockholm, 141 86

Other trials in Sweden

Switzerland2 sites

  • Kantonsspital Kardiologie

    Basel, 4031

  • Inselspital Bern, Schweizer Herz- und Gefasszentrum

    Bern, 3010

Other trials in Switzerland

Austria1 site

  • A.ö. Krankenhaus der Elisabethinen Linz

    Linz, 4010

Other trials in Austria

United Kingdom1 site

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

Other trials in United Kingdom

About this study

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.

Read the detailed description

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.

Being tested
Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
Keywords
Refined ventricular pacing
Medical subject headings
Bradycardia, Sick Sinus Syndrome, Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2Device

  • Required pacemaker settingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization

Secondary outcomes (4)

  1. 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

  2. Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization

  3. 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

  4. Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00156741
Sponsor's protocol ID
CMD 287
Status last verified
Sep 2005
First submitted
7 Sep 2005
Last updated
2 Aug 2011
Results posted
No

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. doi: 10.1056/NEJM200005113421902.

    PubMed 10805823

  • 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. doi: 10.1016/s0735-1097(01)01326-2.

    PubMed 11451268

  • 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.

    PubMed 9779016

  • 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. doi: 10.1056/NEJM199804163381602.

    PubMed 9545357

  • Danish pacemaker and ICD register. 1999. Pacing Clin Electrophysiol. 2000 Oct;23(10 Pt 2):S1-93. No abstract available.

    PubMed 11758538

  • 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. doi: 10.1001/jama.288.24.3115.

    PubMed 12495391

  • 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. doi: 10.1056/NEJMoa013040.

    PubMed 12063369

  • 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.

  • 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

  • International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1991 Feb 7;324(6):424-8. doi: 10.1056/NEJM199102073240624. No abstract available.

    PubMed 1987468

  • 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. doi: 10.1016/s0140-6736(94)90347-6.

    PubMed 7983951

  • 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. doi: 10.1016/S0140-6736(97)03425-9.

    PubMed 9652562

  • Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Andersen HR. Incidence of atrial fibrillation and thromboembolism in a randomised trial of atrial versus dual chamber pacing in 177 patients with sick sinus syndrome. Heart. 2004 Jun;90(6):661-6. doi: 10.1136/hrt.2003.016063.

    PubMed 15145874

  • 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. doi: 10.1111/j.1540-8159.1996.tb03355.x. No abstract available.

    PubMed 8734740

  • 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. doi: 10.1111/j.1540-8159.1999.tb00345.x.

    PubMed 10588143

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 and Required pacemaker setting in people with Bradycardia; Sick Sinus Syndrome, AV Block, run by Medtronic BRC at 30 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Czechia, Germany, Netherlands, Denmark, Finland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00156741, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.

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