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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00832260
First received: January 29, 2009
Last updated: September 25, 2014
Last verified: September 2014

January 29, 2009
September 25, 2014
January 2009
June 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Pulse width that may be considered as standard value when ACap™ Confirm want to be enabled and in which phase, short, medium or long term Acap™Confirm may be enabled during the patient follow ups according the standard of care. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00832260 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
The short, medium and long term variability of the relation between atrial polarization and Evoked Response. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.

  • Sinus Bradycardia
  • Sinus Node Disease
  • Atrio-ventricular Block
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2013
June 2011   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00832260
CR08004ES
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: José Olagüe de Ros, PhD. Hospital Universitario La Fe
St. Jude Medical
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP