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

November 12, 2013 updated by: Klinik für Kardiologie, Pneumologie und Angiologie

Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unconsciousness, not able to consent
  • < 18 years
  • permanent pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of HV interval
Time Frame: Changes in Baseline to 24 hours
HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation.
Changes in Baseline to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AV-block development after 1 month, 6 months and 12 months
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months

Other Outcome Measures

Outcome Measure
Time Frame
cardiovascular mortality
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

  • Principal Investigator: Malte Kelm, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
  • Principal Investigator: Marc W. Merx, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf
  • Principal Investigator: Dong-In Shin, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (ESTIMATE)

February 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HV-interval prior TAVI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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