Pacing in Left Ventricular Assist Device Recipients
Pace-VAD
Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing
1 other identifier
interventional
15
1 country
1
Brief Summary
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor. The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedStudy Start
First participant enrolled
April 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedJune 2, 2020
May 1, 2020
1.8 years
February 15, 2019
May 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen uptake (pVO2)
1 Day
Secondary Outcomes (1)
Heart rate
1 Day
Study Arms (2)
Peak oxygen uptake test with pacing
OTHERPeak oxygen uptake test with pacing
Peak oxygen uptake test without pacing
SHAM COMPARATORPeak VO2 test without pacing
Interventions
Peak oxygen uptake test with paced heart rate
Peak oxygen uptake test without paced heart rate
Eligibility Criteria
You may qualify if:
- Implanted with a left ventricular assist device
- Implanted with a pace-device ensuring the possibility of pacing
- Age \> 18
You may not qualify if:
- Not able to undergo a peak oxygen uptake test
- No consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finn Gustafssonlead
Study Sites (1)
Rigshospitalet
Copenhagen, DK, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Patients and staff performing the peak oxygen uptake test (pVO2) will be blinded to device regulation. Blinding will be ensured by recruiting a secondary doctor or other staff to regulate pace-settings in relation to the paced pVO2 test while performing sham regulations (or just read pace-settings) in relation to the non-paced pVO2 test. Thus, both patients and investigator are blinded.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 18, 2019
Study Start
April 23, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
June 2, 2020
Record last verified: 2020-05