Sinus BradycardiaIES-ACapNCT00832260
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
An observational study of Sinus Bradycardia and Sinus Node Disease, run by Abbott Medical Devices.
Trial summary
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 whit a Zephyr™ pacemaker implanted, models 5826 and 5820.
Who may be able to join
- Patient has an indication for implantation of a dual-chamber pacemaker;
- Patient is older than 18 years of age
- Patient has signed the study specific Informed consent document.
- Primo implant.
Who cannot join
- Patient is pregnant or nursing
- Patient is less than 18 years of age
- Patient is in New York Heart Association (NYHA) class III and IV.
- Patient has a pacemaker replacement;
- Patient is unable to attend the follow-up visits;
About this study
Official title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
Read the detailed description
The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.
- Medical subject headings
- Sick Sinus Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Measured: 12 months
Secondary outcomes (1)
Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sinus BradycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Olagüe de Ros, PhD., Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832260
- Sponsor's protocol ID
- CR08004ES
- Acronym
- IES-ACap
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2009
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
- ClinicalTrials.gov ID
- NCT00832260
- Acronym / sponsor ID
- IES-ACap / CR08004ES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
Detailed description
The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.
Study design
- Observational model
- Case only
- 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 whit a Zephyr™ pacemaker implanted, models 5826 and 5820.
Key inclusion criteria (4 listed)
- Patient has an indication for implantation of a dual-chamber pacemaker;
- Patient is older than 18 years of age
- Patient has signed the study specific Informed consent document.
- Primo implant.
Key exclusion criteria (5 listed)
- Patient is pregnant or nursing
- Patient is less than 18 years of age
- Patient is in New York Heart Association (NYHA) class III and IV.
- Patient has a pacemaker replacement;
- Patient is unable to attend the follow-up visits;
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
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Time frame: 12 months
1 secondary outcome
Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
José Olagüe de Ros, PhD. principal investigator
Hospital Universitario La Fe
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Bradycardia and Sinus Node Disease, run by Abbott Medical Devices.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2019.