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Trial record 42 of 69 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

Real Life Automatic Atrial Capture Device Control

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ClinicalTrials.gov Identifier: NCT02400983
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Dr.Massimo Giammaria, 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.

Condition or disease Intervention/treatment
Sinus Bradycardia Sinus Node Disease Atrio-ventricular Block Heart Failure Device: Pacemaker, ICD

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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 : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine





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. [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Relationship with pulse width [ Time Frame: 6 Months ]
  2. Clinical equivalence of automatic and manual thresholds tests results. [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients had undergone first implantation or device replacement with a device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400983


Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
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Principal Investigator: Massimo Giammaria Maria Vittoria Hospital

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Responsible Party: Dr.Massimo Giammaria, MD, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT02400983     History of Changes
Other Study ID Numbers: 01
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Dr.Massimo Giammaria, Maria Vittoria Hospital:
ACAP, Automatic Algorithm
Additional relevant MeSH terms:
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Bradycardia
Sick Sinus Syndrome
Atrioventricular Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Arrhythmia, Sinus
Heart Block
Cardiac Conduction System Disease