DEtermining Accuracy and TrEnding CharacTerization of AF

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: SJM Confirm ICM

• Registration Number: NCT01673256
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Study Start: 2012-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-01-05
• Results First Submitted QC: 2015-03-16
• Results First Posted: 2015-03-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SJM Confirm ICM Observational Group	SJM Confirm ICM	-

Primary Outcome Measures

Name	Time	Method
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.	4 days after Holter starts	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.

Trial Locations

Locations (13)

Rhön-Klinikum, Herz- und Gefäß-Klinik; 🇩🇪 Bad Neustadt, Germany

Charite, Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Klinikum Ingolstadt GmbH; 🇩🇪 Ingolstadt, Germany

Hagahospital; 🇳🇱 Den Haag, Netherlands

Klinikum Coburg; 🇩🇪 Coburg, Germany

Hegau-Bodensee-Kliniken; 🇩🇪 Singen, Germany

University of Dresden - Heart Center; 🇩🇪 Dresden, Germany

Klinikum Frankfurt Höchst GmbH; 🇩🇪 Frankfurt, Germany

Herz -und Diabeteszentrum; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Isar Heart Center; 🇩🇪 Munich, Germany

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Netherlands

Schwarzwald-Baar Klinikum GmbH; 🇩🇪 Villingen Schwenningen, Germany