Pacing in Heart Failure With Preserved LVEF

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: CRT-pacemaker device set to Routine Medical Therapy + LVP; Device: CRT-pacemaker device set to Routine Medical Therapy + BiVP; Device: CRT-pacemaker device set to Routine Medical Therapy

• Registration Number: NCT03215849
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.

The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.

All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:

Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2023-07-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
2. LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
3. Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
4. Adults (over 18 years)
5. Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
6. Two weeks or more following final dose of vaccination against coronavirus.

Exclusion Criteria

1. Inability to provide informed consent.
2. Enrolment in other clinical studies.
3. BMI more than 35
4. Objective evidence of significant lung disease on formal lung function testing
5. Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
6. Acute coronary syndrome (within the previous three months)
7. History of atrial fibrillation (AF)
8. Renal insufficiency requiring haemodialysis
9. Life expectancy less than 6 months
10. Prosthetic heart valves
11. Blood coagulation disorders
12. Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
13. Currently pregnant, or intending to conceive.
14. Recent positive Covid test (up to 14 days prior to pre-assessment).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Routine Medical Therapy + LVP	CRT-pacemaker device set to Routine Medical Therapy + LVP	Routine Medical Therapy + LVP
Routine Medical Therapy + BiVP	CRT-pacemaker device set to Routine Medical Therapy + BiVP	Routine Medical Therapy + BiVP
Routine Medical Therapy	CRT-pacemaker device set to Routine Medical Therapy	Routine Medical Therapy

Primary Outcome Measures

Name	Time	Method
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in rest and exercise E/E' on echocardiography across the three pacing states	12 weeks
Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states	12 weeks
Change in LV area between rest and exercise across the three pacing states	12 weeks

Trial Locations

Locations (1)

University Hospital Wales; 🇬🇧 Cardiff, United Kingdom