Clinical trial NCT03337763: A Prospective Pilot Study (BIO|SELECT Pilot)
Official title: A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: LV-LV conduction delay
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient collective consists of heart failure patients with CRT-D indication according to clinical routine. Two hundred patients with successful device implantation will be enrolled in the clinical investigation.

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.

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

Primary outcomes:
measure: Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: Rate of arrhythmia episodes
timeFrame: through study completion, an average of 7 months
measure: Influence by baseline characteristics
timeFrame: through study completion, an average of 7 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
Study officials:
References: