NCT00915720

Brief Summary

This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2010

Enrollment Period

3.3 years

First QC Date

June 4, 2009

Last Update Submit

July 19, 2011

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationSurgical AblationImplanted loop recorderAtrial Fibrillation Ablation

Outcome Measures

Primary Outcomes (1)

  • Incidence/Duration of atrial and tachyarrhythmias post AF ablation

    14 months

Eligibility Criteria

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

Patients undergoing surgical atrial fibrillation

You may qualify if:

  • Patients undergoing surgical atrial fibrillation ablation
  • Patients must be 18 years or older

You may not qualify if:

  • Patients unwilling to comply with the follow up schedule
  • Pregnant or breastfeeding patients
  • Patients currently participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoracic & Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John H Ip, MD

    Thoracic & Cardiovascular Healthcare Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 20, 2011

Record last verified: 2010-07

Locations

US(1)