NCT02400983

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 24, 2015

Last Update Submit

March 30, 2015

Conditions

Sinus BradycardiaSinus Node DiseaseAtrio-ventricular BlockHeart Failure

Keywords

ACAP, Automatic Algorithm

Outcome Measures

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.

    6 Months

Secondary Outcomes (2)

  • Relationship with pulse width

    6 Months

  • Clinical equivalence of automatic and manual thresholds tests results.

    6 Months

Interventions

Pacemaker, ICDDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sick Sinus SyndromeHeart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Massimo Giammaria

    Maria Vittoria Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03