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SyncAV Study: Investigation of the Efficacy of the SyncAV Fusion Pacing Algorithm on Exercise

NCT03768804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-11-17

No results posted yet for this study

Summary

In patients with weak pumping function of the heart, uncoordinated contraction of the chambers can be corrected using a cardiac resynchronization therapy ("CRT") pacemaker. These devices make patients live longer by improving how the heart pumps and reducing symptoms such as breathlessness. However, not all patients benefit from CRT and programming devices optimally can greatly influence success. Predicting the correct timings of contraction between the atria (top chambers of the heart) and the ventricles (bottom chambers), as well as between the left and right ventricles, especially when heart rate increases during exercises, is challenging.

A new approach to optimizing CRT programming has been proposed known as 'fusion-pacing'. This allows the electrical wave from the heart's own conduction system to merge or fuse with the impulse from the pacemaker in the left ventricle. The timing of the pacemaker's impulse is continuously adjusted to measurements the device makes of the hearts natural conduction. What is not clear is how effective 'fusion-pacing' is during exercise when the hearts natural conduction changes rapidly and unpredictably. We plan to investigate this by monitoring the electrocardiogram ("ECG") whilst accurately measuring exercise performance and ability during a cardiopulmonary exercise test ("CPET") on an exercise bike. We will also ask participants to rate their perceived exercise intensity to see whether fusion pacing improves ECG resynchronization, exercise performance, and patients' symptoms compared to standard programming.

Conditions

  • Heart Failure, Systolic

Interventions

OTHER

SyncAV algorithm on

Cardiac Resynchronisation Device will be set to have the SyncAV algorithm on for the duration of the cardiopulmonary exercise test ("CPET"), before being reset to pre-existing settings

OTHER

SyncAV algorithm off

ardiac Resynchronisation Device will be set to have the SyncAV algorithm off and a fixed AV delay, for the duration of the CPET, before being reset to pre-existing settings

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Neil Herring, BMBCh MRCP · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768804 on ClinicalTrials.gov