ArrhythmiaNCT00135174
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
An observational study of Arrhythmia and Heart Diseases, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Heart Diseases
- How many people
- 1,526 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2003to Jan 2012
- Phase
- Observational
- 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
Study population: Patients requiring a PM for conventional reasons.
Who may be able to join
- Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study.
Who cannot join
- Patients are not eligible if they refuse to sign informed consent on use of personal medical data.
- Patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker
- Patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Julius Center for Primary Care and Health Sciences, University Medical Center Utrecht
Utrecht, Utrecht, 3508 GA
About this study
Official title: Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.
Read the detailed description
Specific objectives :
- To determine the incidence of complications occurring in the first year after implantation of a pacemaker.
- To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation.
- To determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year.
- To determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent.
- To determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).
- Conditions
- Arrhythmia, Heart Diseases
- Keywords
- Pacemaker, routine, follow-up, complications, Quality of Life
- Medical subject headings
- Arrhythmias, Cardiac, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startSep 2003
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,526 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- College of Health Insurers/Society of Academic Hospitals,, Dutch Working Group on Cardiac Pacing,, Foundation Pacemaker Registry in The Netherlands,
- Investigators
- Norbert van Hemel, M.D., Study chair, University of Utrecht, Julius Center for Primary Care and Health SciencesKarel G Moons, PhD, Study chair, University of Utrecht, Julius Center for Primary Care and Health SciencesDiederick E Grobbee, M.D., Study chair, University of Utrecht, Julius Center for Primary Care and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135174
- Sponsor's protocol ID
- CVZ/VAZ 01236
- Status last verified
- Jun 2008
- First submitted
- 23 Aug 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Risk of heart failure- and cardiac death gradually increases with more right ventricular pacing. Int J Cardiol. 2015 Apr 15;185:95-100. doi: 10.1016/j.ijcard.2015.03.053. Epub 2015 Mar 5.
PubMed 25804349Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Prognosis of the bradycardia pacemaker recipient assessed at first implantation: a nationwide cohort study. Heart. 2013 Nov;99(21):1573-8. doi: 10.1136/heartjnl-2013-304445. Epub 2013 Aug 22.
PubMed 23969476Udo EO, van Hemel NM, Zuithoff NP, Nijboer H, Taks W, Doevendans PA, Moons KG. Long term quality-of-life in patients with bradycardia pacemaker implantation. Int J Cardiol. 2013 Oct 3;168(3):2159-63. doi: 10.1016/j.ijcard.2013.01.253. Epub 2013 Feb 28.
PubMed 23453871Udo EO, van Hemel NM, Zuithoff NP, Dijk WA, Hooijschuur CA, Doevendans PA, Moons KG. Pacemaker follow-up: are the latest guidelines in line with modern pacemaker practice? Europace. 2013 Feb;15(2):243-51. doi: 10.1093/europace/eus310. Epub 2012 Oct 24.
PubMed 23097223Udo EO, van Hemel NM, Zuithoff NP, Kelder JC, Crommentuijn HA, Koopman-Verhagen AM, Voskuil T, Doevendans PA, Moons KG. Long-term outcome of cardiac pacing in octogenarians and nonagenarians. Europace. 2012 Apr;14(4):502-8. doi: 10.1093/europace/eur329. Epub 2011 Oct 23.
PubMed 22024601
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study
- ClinicalTrials.gov ID
- NCT00135174
- Acronym / sponsor ID
- CVZ/VAZ 01236
- Conditions
- Arrhythmia, Heart Diseases
- Keywords
- Pacemaker, routine, follow-up, complications, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,526 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- College of Health Insurers/Society of Academic Hospitals,, Dutch Working Group on Cardiac Pacing,, Foundation Pacemaker Registry in The Netherlands,
- Study start
- Sep 2003
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.
Detailed description
Specific objectives :
- To determine the incidence of complications occurring in the first year after implantation of a pacemaker.
- To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation.
- To determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year.
- To determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent.
- To determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a PM for conventional reasons.
Key inclusion criteria (1 listed)
- Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study.
Key exclusion criteria (3 listed)
- Patients are not eligible if they refuse to sign informed consent on use of personal medical data.
- Patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker
- Patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
- Derived from this study: PubMed 25804349Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Risk of heart failure- and cardiac death gradually increases with more right ventricular pacing. Int J Cardiol. 2015 Apr 15;185:95-100. doi: 10.1016/j.ijcard.2015.03.053. Epub 2015 Mar 5.
- Derived from this study: PubMed 23969476Udo EO, van Hemel NM, Zuithoff NP, Doevendans PA, Moons KG. Prognosis of the bradycardia pacemaker recipient assessed at first implantation: a nationwide cohort study. Heart. 2013 Nov;99(21):1573-8. doi: 10.1136/heartjnl-2013-304445. Epub 2013 Aug 22.
- Derived from this study: PubMed 23453871Udo EO, van Hemel NM, Zuithoff NP, Nijboer H, Taks W, Doevendans PA, Moons KG. Long term quality-of-life in patients with bradycardia pacemaker implantation. Int J Cardiol. 2013 Oct 3;168(3):2159-63. doi: 10.1016/j.ijcard.2013.01.253. Epub 2013 Feb 28.
- Derived from this study: PubMed 23097223Udo EO, van Hemel NM, Zuithoff NP, Dijk WA, Hooijschuur CA, Doevendans PA, Moons KG. Pacemaker follow-up: are the latest guidelines in line with modern pacemaker practice? Europace. 2013 Feb;15(2):243-51. doi: 10.1093/europace/eus310. Epub 2012 Oct 24.
- Derived from this study: PubMed 22024601Udo EO, van Hemel NM, Zuithoff NP, Kelder JC, Crommentuijn HA, Koopman-Verhagen AM, Voskuil T, Doevendans PA, Moons KG. Long-term outcome of cardiac pacing in octogenarians and nonagenarians. Europace. 2012 Apr;14(4):502-8. doi: 10.1093/europace/eur329. Epub 2011 Oct 23.
- Webpage with information on study center.Link provided by the sponsor.
- Electronic CRF pages and entire protocol can be viewed here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert van Hemel, M.D. study chair
University of Utrecht, Julius Center for Primary Care and Health Sciences
Karel G Moons, PhD study chair
University of Utrecht, Julius Center for Primary Care and Health Sciences
Diederick E Grobbee, M.D. study chair
University of Utrecht, Julius Center for Primary Care and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Heart Diseases, run by UMC Utrecht at 1 site in Netherlands.
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 1 inclusion and 3 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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135174, which also lists 5 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 17 Jun 2008.