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
  Purpose

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


Condition
Sinus Bradycardia
Sinus Node Disease
Atrio-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.

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: August 27, 2014
Last Updated: September 25, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on October 22, 2014