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

JMACCT ID: JMA-IIA00195

Registered date:04/09/2014

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 enrollment: 10/12/2014
• Target sample size: 188
• Countries of recruitment: Japan
• Study type: OBSERVATIONAL

Outcome(s)

• Primary Outcome: Percentages 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 maximum: No Limit
• Gender: BOTH

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

• Primary Sponsor: Abbott Medical Japan Co., Ltd.
• Source(s) of Monetary Support: Abbott Medical Japan Co., Ltd.