Real Life Automatic Atrial Capture Device Control

• Sponsor: Maria Vittoria Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02400983
• Collaborator: (none)
• Enrollment: 318
• Duration (Months): 13.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Bradycardia; Sinus Node Disease; Atrio-ventricular Block; Heart Failure	Device: Pacemaker, ICD

Study Design

• Study Type: Observational
• Actual Enrollment: 318 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Outcome Measures

Primary Outcome Measures

1. 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

1. Relationship with pulse width [6 Months]

2. Clinical equivalence of automatic and manual thresholds tests results. [6 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Maria Vittoria Hospital

Investigators

• Principal Investigator: Massimo Giammaria, Maria Vittoria Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr.Massimo Giammaria, MD, Maria Vittoria Hospital
• ClinicalTrials.gov Identifier: NCT02400983
• Other Study ID Numbers: 01
• First Posted: Mar 27, 2015
• Last Update Posted: Apr 1, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Dr.Massimo Giammaria, MD, Maria Vittoria Hospital: ACAP, Automatic Algorithm
• Additional relevant MeSH terms: Bradycardia; Sick Sinus Syndrome; Atrioventricular Block

Study Results

No Results Posted as of Apr 1, 2015