Real Life Automatic Atrial Capture Device Control

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

Completed

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Key information

Conditions

Sinus Bradycardia Arrhythmia, Sinus Arrhythmias, Cardiac Atrio-Ventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome Sinus Node Disease

Age range

18 year and older

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pacemaker, ICD

Device

Primary outcomes

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 outcomes

Relationship with pulse width

Time frame: 6 Months
Clinical equivalence of automatic and manual thresholds tests results.

Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Maria Vittoria Hospital

Other

Registry information

Official study title

Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 27, 2015
Registry last updated: Apr 1, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed