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

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.

Conditions studied

Sinus Bradycardia
Sinus Node Disease
Atrio-ventricular Block
Heart Failure

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Keywords

ACAP, Automatic Algorithm

In context

Sick Sinus Syndrome

93 studies on the registry are indexed under Sick Sinus Syndrome; 18 are open to participants now.

This study's enrollment of 318 is close to the median of 300 across 29 observational studies indexed under Sick Sinus Syndrome.

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Lead sponsor

Maria Vittoria Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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

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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

Study design

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

Interventions

DevicePacemaker, ICD

What researchers measure

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

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Jan 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 24, 2015
First posted: Mar 27, 2015
Start: Jan 2014
Primary completionActual: Jan 2015
CompletionActual: Mar 2015
Last update: Apr 1, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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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Discussion

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