Pacing in Heart Failure With Preserved LVEF

NCT03215849 | Enrolling By Invitation DMC

• 1 other identifier: 203878
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in LV area between rest and exercise 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 rest and exercise E/E' on echocardiography across the three pacing states

  12 weeks

Study Arms (3)

Routine Medical Therapy

SHAM COMPARATOR

Routine Medical Therapy

Device: CRT-pacemaker device set to Routine Medical Therapy

Routine Medical Therapy + LVP

EXPERIMENTAL

Routine Medical Therapy + LVP

Device: CRT-pacemaker device set to Routine Medical Therapy + LVP

Routine Medical Therapy + BiVP

EXPERIMENTAL

Routine Medical Therapy + BiVP

Device: CRT-pacemaker device set to Routine Medical Therapy + BiVP

Interventions

CRT-pacemaker device set to Routine Medical Therapy DEVICE

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy

Routine Medical Therapy

CRT-pacemaker device set to Routine Medical Therapy + LVP DEVICE

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP

Routine Medical Therapy + LVP

CRT-pacemaker device set to Routine Medical Therapy + BiVP DEVICE

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP

Routine Medical Therapy + BiVP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
• Adults (over 18 years)
• Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
• Two weeks or more following final dose of vaccination against coronavirus.

You may not qualify if:

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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Cardiff Metropolitan University: collaborator

Study Sites (1)

University Hospital Wales

Cardiff, CF14 4UJ, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Zaheer Yousef

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 12, 2017
• Study Start: July 20, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)