NCT01801098

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

February 6, 2013

Last Update Submit

November 12, 2013

Conditions

Symptomatic Aortic Valve Stenosis

Keywords

TAVIcomplete AV-blockHV-intervalpermanent pacemaker

Outcome Measures

Primary Outcomes (1)

  • Determination of HV interval

    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 Outcomes (1)

  • AV-block development after 1 month, 6 months and 12 months

    1 month, 6 months and 12 months

Other Outcomes (1)

  • cardiovascular mortality

    1 month, 6 months and 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 28, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

DE(1)