A Prospective Pilot Study (BIO|SELECT Pilot)

Completed

• Conditions: Heart Failure

• Registration Number: NCT03337763
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.

Detailed Description

Enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-Lead ECG) prior to the implantation of Biotronik CRT-D and QP lead featured with MultiPole Pacing parameter. At implantation, LV-LV conduction delays are measured in predefined LV pacing and sensing configurations. One month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming MultiPole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. Patients are subsequently followed up at four and seven month post implantation to acquire the LV-LV conduction delays and echo readings, etc. at the time.

Study Timeline

• Study First Submitted: 2017-10-24
• Study Start: 2017-11-07
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

To be eligible for the study enrollment, candidate patients must meet all of the following criteria

• Indicated for a CRT-D implantation
• Has never received CRT
• Planned to be implanted with a quadripolar LV Lead, and CRT-D with MultiPole pacing feature, both manufactured by BIOTRONIK
• Geographically stable and willing to comply with the required follow-up schedule
• With written informed consent

Exclusion Criteria

Candidate patients will not be eligible if either of the following criteria is applicable

• Underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than CRT implantation
• Life expectancy is less than a year
• Can not be programmed to MultiPole pacing "ON"
• Does not agree to the concept of HomeMonitoring System
• With known pregnancy
• At age below 20 years
• Participated in another interventional clinical study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters	through study completion, an average of 7 months	LV-LV/RV-LV intra-cardiac conduction time will be obtained at each time frame, and correlation will be investigated with variation of multiple hemodynamic parameters from baseline up to seven month follow up.

Secondary Outcome Measures

Name	Time	Method
Influence by baseline characteristics	through study completion, an average of 7 months	An alanysis of the impact of the baseline characteristics on other outcomes
Rate of arrhythmia episodes	through study completion, an average of 7 months	Comparison between patient groups in terms of rate of arrhythmia

Trial Locations

Locations (1)

Kyorin University Hospital; 🇯🇵 Mitaka, Tokyo, Japan