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CompletedNCT02400983Updated Apr 1, 2015

Real Life Automatic Atrial Capture Device Control

An observational study in Sinus Bradycardia, Sinus Node Disease and Atrio-ventricular Block, sponsored by Maria Vittoria Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by Maria Vittoria Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
318
Ages
18 Years and older
01

Study 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.

02

Conditions studied

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

Keywords

  • ACAP, Automatic Algorithm
03

Who can participate

Ages eligible
18 Years and older
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

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

Exclusion Criteria:

  • Atrial fibrillation
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
318 participants (actual)
Patient registry
No

Interventions

  • DevicePacemaker, ICD
05

What researchers measure

Primary outcomes

  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 outcomes

  1. Relationship with pulse width

    Time frame: 6 Months

  2. Clinical equivalence of automatic and manual thresholds tests results.

    Time frame: 6 Months

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02400983
Lead sponsor
Maria Vittoria Hospital
Responsible party
Dr.Massimo Giammaria (MD, Maria Vittoria Hospital) — Principal investigator
First posted
Mar 27, 2015
Start date
Jan 2014
Primary completion
Jan 2015
Completion
Mar 2015
Last update
Apr 1, 2015

Study contacts

Massimo Giammaria
principal investigator · Maria Vittoria Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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