Pacing in Left Ventricular Assist Device Recipients (Pace-VAD)

Finn Gustafsson

Status: Unknown

Conditions: Chronotropic Incompetence; Pacing; Heart Rate

Treatments: Other: Peak oxygen uptake test with pacing; Other: Peak oxygen uptake test without pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT03844516

H-17029488

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Peak oxygen uptake test with pacing

Other group

Description:

Peak oxygen uptake test with pacing

Treatment:

Other: Peak oxygen uptake test with pacing

Peak oxygen uptake test without pacing

Sham Comparator group

Description:

Peak VO2 test without pacing

Treatment:

Other: Peak oxygen uptake test without pacing