Pacing in Heart Failure With Preserved LVEF

Heart Failure Clinical Trial

— MAPPLE  

Official title:

The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03215849
• Other study ID #: 203878
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT-pacemaker device set to Routine Medical Therapy
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
• CRT-pacemaker device set to Routine Medical Therapy + LVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
• CRT-pacemaker device set to Routine Medical Therapy + BiVP
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP

Locations

Country	Name	City	State
United Kingdom	University Hospital Wales	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Cardiff Metropolitan University, Norfolk and Norwich University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in LV area between rest and exercise across the three pacing states		12 weeks
Secondary	Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states		12 weeks
Secondary	Change in rest and exercise E/E' on echocardiography across the three pacing states		12 weeks