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Completed

NCT Number: NCT00832260

IES-ACap: 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: IES-ACap

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jan 30, 2009
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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