Reveal® XT Performance Trial (XPECT) | NCT00680927

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

May 15, 2008

First Submission Date that Met QC Criteria

May 15, 2008

First Posted Date

May 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.

Detailed Description

The study is a prospective, non-randomized, multi-center international post-market study.

The study will be conducted at 20-30 centers primarily in Europe. The study will be conducted at least in Germany, Austria, Switzerland, The Netherlands, and the Czech Republic. Study centers from Canada may also participate, depending on the timelines for regulatory approval and commercial release of the Reveal® XT in this region.

It is expected that between 140 and 200 patients will be enrolled to ensure that at least 47 patients are included to assess the first primary objective and at least 60 patients to assess the second primary objective.

The primary objective is to quantify the AF detection performance of the device.

The patient population will be assessed in two separate cohorts. The first primary objective is to quantify the 24-hour AF burden accuracy in patients with more than 1% AF burden.

The second primary objective is to quantify the detection accuracy of non-arrhythmia in patients with 1% or less AF burden.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

247Actual

Name	Type	Description	Arm Group Labels	Other Names
46 hrs Holter ECG recording	Other	Maximum of 2 46 hrs external Holter ECG recordings are required.

Measure	Description	Time Frame
Atrial Fibrillation Burden (AF Burden)		46 hrs

Measure	Description	Time Frame
AF episode detection accuracy and AF episode duration accuracy		46 hrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is willing and able to provide his/her informed consent
Patient has been implanted with a Reveal® XT
Patient fulfills at least one of the following three additional requirements
1. is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or
2. has documented frequent AF or frequent symptoms attributable to AF or
3. has undergone PV ablation within the last 6 months and still has symptoms attributable to AF

Exclusion Criteria:

Patient has an implanted pacemaker or ICD
Patient has persistent or permanent AF
Patient is allergic to adhesive ECG electrodes
The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period
Patient is participating in another study that is expected to compromise the results of this study
Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
Patient is pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guido H. Rieger, MD	Medtronic Bakken Research Center B.V.	Study Director
Gerhard Hindricks, MD, PhD	Heart Center Leipzig - University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LKH - Universitätskliniken		Innsbruck		A-6020	Austria
A.ö. Krankenhaus der Elisabethinen Linz

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16547207	Background	Nergardh A, Frick M. Perceived heart rhythm in relation to ECG findings after direct current cardioversion of atrial fibrillation. Heart. 2006 Sep;92(9):1244-7. doi: 10.1136/hrt.2005.082156. Epub 2006 Mar 17.
16009793	Background	Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms