Real Life Automatic Atrial Capture Device Control

Heart Failure Clinical Trial

Official title:

Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400983
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: March 30, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Maria Vittoria Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrio-ventricular Block
• Atrioventricular Block
• Bradycardia
• Heart Failure
• Sinus Bradycardia
• Sinus Node Disease

Intervention

Device:
• Pacemaker, ICD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Relationship with pulse width		6 Months	No
Secondary	Clinical equivalence of automatic and manual thresholds tests results.		6 Months	No