Heart Failure, Wide QRS Complex
Conditions
Keywords
atrial pacing, cardiac resynchronization therapy, heart failure, implantable cardioverter defibrillator, rate-adaptive pacing
Brief summary
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
Detailed description
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population. Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability. The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.
Interventions
OTHERAtrial pacing support
Use a pacing mode with atrial pacing including a rate-resposive sensor.
OTHERAtrial tracking pacing mode
A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria.
Sponsors
Ospedale Centrale Bolzano
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, cross-over, double-blind, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form; * Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA). * Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.
Exclusion criteria
* Permanent Atrial Fibrillation; * Inability to perform 6MWT; * Suboptimal HF drug therapy; * Heart rate at rest above 50 bpm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| distance walked during the 6MWT | A consecutive 6-month treatment period with the same pacing mode. | distance walked during the 6-minute-walking-test (6MWT) |
Countries
Italy
Outcome results
None listed