Real Life Automatic Atrial Capture Device Control

Overview

The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm algorithm in the automatic management of atrial capture.

Full Title of Study: “Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2015

Interventions

  • Device: Pacemaker, ICD

Clinical Trial Outcome Measures

Primary Measures

  • The main objective of this study is to verify the effectiveness of the new ACAP Confirm ® algorithm in management of atrial capture in both new implants and patients undergoing device replacements with different manufactures atrial leads.
    • Time Frame: 6 Months

Secondary Measures

  • Relationship with pulse width
    • Time Frame: 6 Months
  • Clinical equivalence of automatic and manual thresholds tests results.
    • Time Frame: 6 Months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients had undergone first implantation or device replacement with a Medical device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012 Exclusion Criteria:

  • Atrial fibrillation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maria Vittoria Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr.Massimo Giammaria, MD – Maria Vittoria Hospital
  • Overall Official(s)
    • Massimo Giammaria, Principal Investigator, Maria Vittoria Hospital

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