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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT04231032
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, \>18 years.
2. HCM patients with apical HCM defined as apical hypertrophy with apical LV systolic obliteration and the presence of characteristic ECG changes. Participants with a mixed cardiac phenotype will be considered if they also meet these criteria and do not have resting outflow tract obstruction.
3. A programmable intracardiac pacing device with a right atrial lead and an apically / low septal located right ventricular lead.
4. Willing and able to provide informed consent.
Exclusion Criteria:
1. Outflow tract obstruction \>50 mmHg at rest due to systolic anterior mitral movement.
2. Evidence of high-grade heart block.
3. Moderate or severe primary valvular disease.
4. Unrevascularised, known, significant coronary disease: the significance of any known coronary disease will be determined after discussion with an independent clinician.
5. Atrial fibrillation at the time of randomisation.
6. Inability to undergo CMR with adenosine stress and gadolinium contrast imaging.
7. Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04231032
Study Brief:
Protocol Section:
NCT04231032