DEtermining Accuracy and TrEnding CharacTerization of AF

Atrial Fibrillation Clinical Trial

Official title:

DEtermining Accuracy and TrEnding CharacTerization of AF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673256
• Other study ID #: DETECT AF
• Status: Completed
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• SJM Confirm ICM

Locations

Country	Name	City	State
Germany	Rhön-Klinikum, Herz- und Gefäß-Klinik	Bad Neustadt
Germany	Herz -und Diabeteszentrum	Bad Oeynhausen
Germany	Charite, Campus Virchow-Klinikum	Berlin
Germany	Klinikum Coburg	Coburg
Germany	University of Dresden - Heart Center	Dresden
Germany	Klinikum Frankfurt Höchst GmbH	Frankfurt
Germany	Klinikum Ingolstadt GmbH	Ingolstadt
Germany	Herzzentrum Leipzig	Leipzig
Germany	Isar Heart Center	Munich
Germany	Hegau-Bodensee-Kliniken	Singen
Germany	Schwarzwald-Baar Klinikum GmbH	Villingen Schwenningen
Netherlands	Hagahospital	Den Haag
Netherlands	Albert Schweitzer Hospital	Dordrecht

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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