NCT01673256

Brief Summary

The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
2 countries

13 active sites

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

First Submitted

Initial submission to the registry

August 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 18, 2015

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

August 22, 2012

Results QC Date

January 5, 2015

Last Update Submit

February 1, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.

    Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.

    4 days after Holter starts

Study Arms (1)

SJM Confirm ICM Observational Group

Device: SJM Confirm ICM

Interventions

SJM Confirm ICMDEVICE
SJM Confirm ICM Observational Group

Eligibility Criteria

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

Primary Care Clinic

You may qualify if:

  • The subject has been implanted with a SJM Confirm ICM, DM2102.
  • The subject has or is suspected to have paroxysmal AF.
  • The subject is ≥ 18 years of age.
  • The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

You may not qualify if:

  • The subject has persistent (\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \>1 year) or permanent AF (not attempting to restore sinus rhythm).
  • The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
  • The subject has a contraindication to Holter recording.
  • The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
  • The subject is unable to comply with the follow up schedule.
  • The subject is participating in another investigational device or drug investigation.
  • The subject is pregnant or is planning to become pregnant during the duration of the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Rhön-Klinikum, Herz- und Gefäß-Klinik

Bad Neustadt an der Saale, Germany

Location

Herz -und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

Charite, Campus Virchow-Klinikum

Berlin, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

University of Dresden - Heart Center

Dresden, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt, Germany

Location

Klinikum Ingolstadt GmbH

Ingolstadt, 85049, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Isar Heart Center

Munich, 80331, Germany

Location

Hegau-Bodensee-Kliniken

Singen, Germany

Location

Schwarzwald-Baar Klinikum GmbH

Villingen-Schwenningen, Germany

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Hagahospital

The Hague, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kyle Brunner
Organization
St. Jude Medical Inc.
kbrunner02@sjm.com
651.756.3482

Study Officials

  • Thorsten Lewalter, MD

    Isar Heart Center Munich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 27, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 5, 2019

Results First Posted

March 18, 2015

Record last verified: 2019-02

Locations

DE(11)NL(2)