A Prospective Pilot Study (BIO|SELECT Pilot)

Heart Failure Clinical Trial

Official title:

A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337763
• Other study ID #: CR023
• Status: Completed
• Start date: November 7, 2017
• Est. completion date: October 7, 2019

Study information

• Verified date: January 2021
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Japan	Kyorin University Hospital	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters	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.	through study completion, an average of 7 months
Secondary	Rate of arrhythmia episodes	Comparison between patient groups in terms of rate of arrhythmia	through study completion, an average of 7 months
Secondary	Influence by baseline characteristics	An alanysis of the impact of the baseline characteristics on other outcomes	through study completion, an average of 7 months