Overview
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Description
HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.
Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.
No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.
Eligibility
Inclusion Criteria:
- 18 to 80 years old
- Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
- Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
- Ability to provide informed consent
Exclusion Criteria:
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
- Spinal instability (or use of spinal orthoses, unless medically approved)
- Deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position
- Uncontrolled autonomic dysreflexia
- Medical instability
- Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP \> 140 mmHg, DBP \> 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia
- Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study
- Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device
- Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg
- Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device
- Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion of at least 100° and extension of at least 0°
- Heterotopic ossification
- Pregnant or breastfeeding women
- Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
- Requires assisted ventilation.
- Scoliosis \>40-50º Cobb angle.
- Presence of pacemakers, defibrillators, or other non-compatible electronic implants.
- Open wounds, infections, or active irritation at the electrode placement sites.
- Severe dermatological conditions in the stimulation area.
- Uncontrolled active epilepsy.
- Malignant tumors in the area of application.
- Severe loss of sensation in the areas where electrodes are to be placed.
- Medical conditions where electrical stimulation is contraindicated by physician recommendation.
- Inability to communicate pain, discomfort, or adverse reactions during stimulation.
- Venous thrombosis, thrombophlebitis, or severe arterial obstruction.
- Chronic venous insufficiency with significant varicosities.
- Hemophilia.
- Ongoing infectious process or fever.
- Presence of metallic implants in the flow area between the electrodes
