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 23, 2013
Last verified: September 2013
  Purpose

The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.


Condition
Bradycardia
Atrial Ventricular Block

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: January 2009
Study Completion Date: September 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 NYHA class III and IV.
  • Patient has a pacemaker replacement;
  • Patient is unable to attend the follow-up visits;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832260

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832260     History of Changes
Other Study ID Numbers: CR08004ES
Study First Received: January 29, 2009
Last Updated: September 23, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014