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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 September 2021
Main ID:	NCT02559011
Date of registration:	21/09/2015
Prospective Registration:	Yes
Primary sponsor:	University Hospital Inselspital, Berne
Public title:	Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device Reveal
Scientific title:	Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
Date of first enrolment:	March 2016
Target sample size:	100
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02559011
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Switzerland

Contacts

Name:	Stephan Windecker, Prof. Dr. med.
Address:
Telephone:
Email:
Affiliation:	Bern University Hospital, Dep. of Cardiology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Severe symptomatic aortic valve stenosis undergoing TAVI

Exclusion Criteria

- Missing IC

- Pacemaker, internal cardioverter-defibrillator or cardiac resynchronization therapy
(CRT) device at the time of screening

- Anatomic or clinical contraindications for TAVI or REVEAL insertion

- Patient currently participating in another study evaluating a new transcatheter valve
prosthesis or a new drug

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Intervention(s)

Primary Outcome(s)

Number of patients with incidence of new onset atrial fibrillation and complete AVB within 12 months after TAVI [Time Frame: up to 12 months]

Secondary Outcome(s)

Number of patients with resolution of atrial Fibrillation [Time Frame: up to 12 months]

Number of patients with cardiovascular mortality [Time Frame: up to 12 months]

Number of patients with pacemaker Implantation [Time Frame: up to 12 months]

Number of patients with presyncope and syncope [Time Frame: up to 12 months]

Number of patients with stroke [Time Frame: up to 12 months]

Number of patients with cardiac death due to arrhythmias [Time Frame: up to 12 months]

Number of patients with resolution of Atrium Ventricular Block (AVB) after TAVI with permanent pacemaker (PPM) implantation [Time Frame: up to 12 months]

Secondary ID(s)

2015_09_21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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