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Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients

NCT02768064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-05-11

No results posted yet for this study

Summary

During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).

All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.

The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.

PMK Complications seen include:

* Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
* Infection
* Electrode dislocation causing In-effective pacing (and/or sensing)
* Prolonged bed rest
* Prolonged hospitalization
* Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

temporary pacemaker insertion

Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Amir Orlev, Dr · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768064 on ClinicalTrials.gov