Real Life Automatic Atrial Capture Device Control

Completed

• Conditions: Sinus Node Disease; Heart Failure; Sinus Bradycardia; Atrio-ventricular Block

• Registration Number: NCT02400983
• Lead Sponsor: Maria Vittoria Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 318

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	6 Months

Secondary Outcome Measures

Name	Time	Method
Relationship with pulse width	6 Months
Clinical equivalence of automatic and manual thresholds tests results.	6 Months