A Prospective Pilot Study (BIO|SELECT Pilot)

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of arrhythmia episodes | Comparison between patient groups in terms of rate of arrhythmia | through study completion, an average of 7 months | 
| Influence by baseline characteristics | An alanysis of the impact of the baseline characteristics on other outcomes | through study completion, an average of 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LV-LV conduction delay