Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT03768804
Eligibility Criteria:
Inclusion Criteria:
* 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").
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03768804
Study Brief:
Protocol Section:
NCT03768804