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

NCT03768804 | Unknown

• 1 other identifier: 13808
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac resynchronisation therapy; Fusion pacing; SyncAV

Outcome Measures

Primary Outcomes (2)

• Exercise capacity

  Exercise capacity as measured by cardiopulmonary exercise testing ("CPET") including blood sampling

  1 Year

• BORG-RPE rating

  Borg rating of perceived exertion ("Borg-RPE") during CPET

  1 Year

Secondary Outcomes (3)

• QRS duration

  1 Year

• Exercise duration

  1 Year

• PR duration

  1 Year

Study Arms (2)

SyncAV algorithm on

OTHER

Device randomised to have SyncAV on, with delta programmed to the value which gives the narrowest QRS duration at rest and pseudo left ventricular ("LV") only pacing

Other: SyncAV algorithm on

SyncAV algorithm off

OTHER

Device randomised to have SyncAV off, with a fixed sensed atrioventricular ("AV") delay of 120ms or shorter if necessary to prevent fusion, and biventricular ("BiV") pacing

Other: SyncAV algorithm off

Interventions

SyncAV algorithm on OTHER

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

SyncAV algorithm on

SyncAV algorithm off OTHER

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

SyncAV algorithm off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and able to give informed consent.
• Patients with existing cardiac resynchronization therapy ("CRT") devices able to utilise the SyncAV algorithm, implanted ≥6 months and under follow up at Oxford University Hospitals National Health Service ("NHS") Foundation Trust.
• Evidence of response to CRT, defined as functional improvement or left ventricular ("LV") remodelling on imaging.
• Sinus rhythm and PR interval \<250ms.
• Able to exercise to perform cardiopulmonary exercise testing ("CPET").

You may not qualify if:

• Pregnancy or breast feeding.
• Atrial fibrillation or atrial tachycardia.
• Underlying 2nd or 3rd degree heart block.
• PR interval ≥250ms.
• Chronotropic incompetence, defined as use of rate-response algorithm or ≥80% atrial pacing.
• Any concurrent condition contraindicating use of CPET.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Department of Physiology, Anatomy and Genetics, University of Oxford

Oxford, Oxfordshire, OX1 3PT, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Neil Herring, BMBCh MRCP

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomised crossover study

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: May 31, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)