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IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm. (IES-ACap)

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ClinicalTrials.gov Identifier: NCT00832260
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : September 8, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Condition or disease
Sinus Bradycardia Sinus Node Disease Atrio-ventricular Block

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

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Study Start Date : January 2009
Primary Completion Date : June 2011
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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). [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.
Criteria

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;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832260


Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: José Olagüe de Ros, PhD. Hospital Universitario La Fe
More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832260     History of Changes
Other Study ID Numbers: CR08004ES
First Posted: January 30, 2009    Key Record Dates
Results First Posted: September 8, 2014
Last Update Posted: October 6, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Atrioventricular Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block