NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00195

Registered date:04/09/2014

Quadra Registry "Study of quadripolar LV lead in lead migration and polarity selection"

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studied-Patient who were successfully implanted with the Abbott Quadripolar CRT-D or CRT-P system.
Date of first enrollment10/12/2014
Target sample size188
Countries of recruitmentJapan
Study typeOBSERVATIONAL
Intervention(s)

Outcome(s)

Primary OutcomePercentages of LV lead migration and dislodgement at 6 months post procedure..
Secondary Outcome-Presence of phrenic nerve stimulation and high threshold caused by LV lead pacing. -Number of pacing vector changes post LV lead implant. -Symptoms of heart failure.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria-Patient who were successfully implanted with the Abbott Quadripolar CRT-D or CRT-P system. -Patient who is >= 20 years of age at the time of enrollment. -Patient who is able to provide written Informed Consent prior to any investigational related procedure.
Exclude criteria-Patient who is unable to comply with the follow-up schedule. -Patient who will not be appropriate to participate in the investigation.

Related Information

Contact

public contact
Name Wataru TAGUCHI
Address Clinical Affairs,Hamarikyu Park Side Place 9F 5-6-10, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Telephone +81-3-3524-1792
E-mail wataru.taguchi@abbott.com
Affiliation Abbott Medical Japan Co., Ltd.
scientific contact
Name Wataru TAGUCHI
Address Clinical Affairs,Hamarikyu Park Side Place 9F 5-6-10, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Telephone +81-3-3524-1792
E-mail
Affiliation Abbott Medical Japan Co., Ltd.