A Prospective Pilot Study (BIO|SELECT Pilot) | NCT03337763

Studies
A Prospective Pilot Study (BIO|SELECT Pilot)

NCT03337763

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Jan 27, 2021Actual

Enrollment

201Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2017Actual

Primary Completion Date

Oct 7, 2019Actual

Completion Date

Oct 7, 2019Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Nov 8, 2017

First Posted Date

Nov 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Patients with known pregnancy is not eligible

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases