Back to resultsAssessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients (BIO|PULSE)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BIOTRONIK CRT-D
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring CRT-D, LV Latency
Eligibility Criteria
Inclusion Criteria:
- Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
- Patient successfully implanted with a left ventricular lead
- High likelihood of LV latency ≥ 40 ms
- LV lead in lateral or postero-lateral position in the coronary venous system
- Patient is able to understand the nature of the clinical investigation
- Patient is willing to undergo the required measurements at the investigation site
- Patient provides written informed consent
- Age ≥ 18 years
Exclusion Criteria:
- Patients with irregular ventricular rhythm due to atrial tachycardia
- Pregnant or breast-feeding women
- Participation in an interventional clinical investigation
Sites / Locations
- Institute for Clinical and Experimental Medicine
- Ceske Budejovice hospital
- Herz- und Diabetiszentrum NRW
- SRH Waldklinikum Gera GmbH
- Universitätsklinikum Gießen und Marburg
- Universitätsklinikum Würzburg
- The Erasmus University Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CRT-D Measurements
Arm Description
Pre-specified measurements and additional follow-ups
Outcomes
Primary Outcome Measures
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
Secondary Outcome Measures
Device-base measured LV latency in the LV IEGM channel and Far Field channel
12-lead ECG-measured LV latency in the channel with earliest QRS onset
Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel
12-lead ECG-measured latency intervals
Full Information
NCT ID
NCT03314675
First Posted
October 16, 2017
Last Updated
November 27, 2018
Sponsor
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT03314675
Brief Title
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
Acronym
BIO|PULSE
Official Title
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Unsuccessful enrollment
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT-D, LV Latency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRT-D Measurements
Arm Type
Other
Arm Description
Pre-specified measurements and additional follow-ups
Intervention Type
Device
Intervention Name(s)
BIOTRONIK CRT-D
Intervention Description
Pre-specified follow-up and measurements
Primary Outcome Measure Information:
Title
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Device-base measured LV latency in the LV IEGM channel and Far Field channel
Time Frame
1 day
Title
12-lead ECG-measured LV latency in the channel with earliest QRS onset
Time Frame
1 day
Title
Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel
Time Frame
1 day
Title
12-lead ECG-measured latency intervals
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
Patient successfully implanted with a left ventricular lead
High likelihood of LV latency ≥ 40 ms
LV lead in lateral or postero-lateral position in the coronary venous system
Patient is able to understand the nature of the clinical investigation
Patient is willing to undergo the required measurements at the investigation site
Patient provides written informed consent
Age ≥ 18 years
Exclusion Criteria:
Patients with irregular ventricular rhythm due to atrial tachycardia
Pregnant or breast-feeding women
Participation in an interventional clinical investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Nordbeck, PD Dr.
Organizational Affiliation
Wuerzburg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Ceske Budejovice hospital
City
České Budějovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Herz- und Diabetiszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
SRH Waldklinikum Gera GmbH
City
Gera
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
The Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
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