NCT00832260

Brief Summary

The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 8, 2014

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

January 29, 2009

Results QC Date

August 27, 2014

Last Update Submit

February 1, 2019

Conditions

Sinus BradycardiaSinus Node DiseaseAtrio-ventricular Block

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.

    12 months

Secondary Outcomes (1)

  • Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).

    12 months

Eligibility Criteria

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

Patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820.

You may qualify if:

  • Patient has an indication for implantation of a dual-chamber pacemaker;
  • Patient is older than 18 years of age
  • Patient has signed the study specific Informed consent document.
  • Primo implant.

You may not qualify if:

  • Patient is pregnant or nursing
  • Patient is less than 18 years of age
  • Patient is in New York Heart Association (NYHA) class III and IV.
  • Patient has a pacemaker replacement;
  • Patient is unable to attend the follow-up visits;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. José Olagüe
Organization
Hospital Universitari i politecnic La Fe
jolague@terra.com
+34 961 24 40 00

Study Officials

  • José Olagüe de Ros, PhD.

    Hospital Universitario La Fe

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2013

Last Updated

February 20, 2019

Results First Posted

September 8, 2014

Record last verified: 2019-02