- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832260
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm. (IES-ACap)
February 1, 2019 updated by: Abbott Medical Devices
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
70
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José Olagüe de Ros, PhD., Hospital Universitario La Fe
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR08004ES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sinus Bradycardia
-
Taipei Medical University WanFang HospitalUnknownAsystole | Sinus Bradycardia | Sinus Arrhythmia | Sinus Tachycardia | Atril FibrillationTaiwan
-
Shanghai Chest HospitalThe Second Affiliated Hospital of Shandong University of traditional Chinese... and other collaboratorsNot yet recruiting
-
China National Center for Cardiovascular DiseasesRecruiting
-
Medtronic BRCUnknownBradycardia; Sick Sinus Syndrome, AV BlockGermany, Denmark, Netherlands, Austria, Czech Republic, United Kingdom, Sweden, Finland, Italy, Russian Federation, Switzerland
-
Maria Vittoria HospitalCompletedHeart Failure | Sinus Bradycardia | Sinus Node Disease | Atrio-ventricular Block
-
LivaNovaCompletedSinus Node Dysfunction | Bradycardia-Tachycardia Syndrome | Paroxysmal Atrioventricular BlockUnited Kingdom, France, Germany, Belgium, Italy
-
University of California, San DiegoCompletedAtrioventricular Block | Cardiac Arrhythmia | Sick Sinus Syndrome | Symptomatic BradycardiaUnited States
-
Boston Scientific CorporationCompletedBradycardia | Sinus Node DysfunctionUnited States, Israel, Singapore, Malaysia, Australia, Canada, China
-
Boston Scientific CorporationCompletedBradycardia | Sinus Node DysfunctionUnited States, Belgium, Germany, Canada, Spain, Sweden, Italy, Malaysia, Denmark, Australia, Austria, United Kingdom, Hong Kong, France, Portugal, Thailand
-
Columbia UniversityCompletedAtrioventricular Block | Sinus BradycardiaUnited States