Status:
COMPLETED
Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Cardiff and Vale University Health Board
Collaborating Sponsors:
Abbott
Cardiff Metropolitan University
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise. A number of m...
Detailed Description
This is an exploratory single-centre, open label, non-randomised, prospective cohort study comparing rate responsive pacing (RRP) with CRT in patients with confirmed HFpEF and chronotropic incompetenc...
Eligibility Criteria
Inclusion
- Confirmed HFpEF as described above
- Chronotropic incompetence as described above
- Ongoing exertional breathlessness of NYHA Grade II or worse
- Ability to understand and sign written consent form
- Males and females, age \>18 years
- Ability to participate in follow-up appointments at 3 and 6 months post-implantation
- Ability to complete a cardiopulmonary exercise test
Exclusion
- Any contraindication to implantation of permanent pacemaker, namely unresolved infective process or sepsis, vascular access difficulties, advanced neoplastic process, expected lifespan less than 1 year or patient choice
- Ejection fraction \<50%
- Known valvular disease graded severe or moderate-to-severe
- Cardiac arrhythmia (paroxysmal or persistent) within 1 year of recruitment
- Exertional chest pain suggestive of angina or personal history of coronary artery disease without subsequent revascularisation, or coronary angiogram within the past 5 years demonstrating \>50% stenosis in ≥ 1 epicardial coronary artery
- Significant chronic lung disease (FEV1 \<80%)
- Inability to complete follow-up process for any reason not defined above
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03338374
Start Date
November 27 2017
End Date
May 30 2022
Last Update
June 2 2023
Active Locations (2)
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1
Cardiff and Vale University Health Board
Cardiff, Mid Glamorgan, United Kingdom, CF14 4XW
2
Cardiff Metropolitan University
Cardiff, Mid Glamorgan, United Kingdom, CF23 6XD