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Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI

NCT ID: NCT01801098

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

Brief Summary

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The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.

The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.

Detailed Description

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Conditions

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Symptomatic Aortic Valve Stenosis

Keywords

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TAVI complete AV-block HV-interval permanent pacemaker

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* symptomatic aortic valve stenosis
* patients screened for TAVI
* written informed consent

Exclusion Criteria

* unconsciousness, not able to consent
* \< 18 years
* permanent pacemaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Malte Kelm, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Marc W. Merx, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf

Dong-In Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Locations

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Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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HV-interval prior TAVI

Identifier Type: -

Identifier Source: org_study_id