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Pacing in Left Ventricular Assist Device Recipients

Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844516
Acronym
Pace-VAD
Enrollment
15
Registered
2019-02-18
Start date
2019-04-23
Completion date
2021-01-31
Last updated
2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronotropic Incompetence, Heart Rate, Pacing

Keywords

Chronotropic incompetence, pacing, heart rate, exercise, peak oxygen uptake

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.

Detailed description

While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value. Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option. In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).

Interventions

OTHERPeak oxygen uptake test with pacing

Peak oxygen uptake test with paced heart rate

OTHERPeak oxygen uptake test without pacing

Peak oxygen uptake test without paced heart rate

Sponsors

Finn Gustafsson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Implanted with a left ventricular assist device * Implanted with a pace-device ensuring the possibility of pacing * Age \> 18

Exclusion criteria

* Not able to undergo a peak oxygen uptake test * No consent

Design outcomes

Primary

MeasureTime frame
Peak oxygen uptake (pVO2)1 Day

Secondary

MeasureTime frame
Heart rate1 Day

Countries

Denmark

Contacts

Primary ContactFinn Gustafsson, MD, PhD, DMSc.
FinnG@dadlnet.dk34459743

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026