The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOcclutech International AB

About this trial

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Eligibility criteria

Qualifiers

Written, informed consent

Age ≥18 years

Presence of chronic symptomatic HF (NYHA class ≥ 2)

Left Atrial Pressure (LAP) > Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg*

Disqualifiers

Life expectancy < 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit

Severe Right Ventricular Dysfunction (TAPSE < 14 mm)

Severe Right Ventricular Dilatation (RV volume ≥ LV volume)

Severe pulmonary hypertension (PASP > 60 mm Hg)

Trial design

Treatments tested in this trial

  • Occlutech Atrial Flow Regulator

Treatment groups

No treatment groups listed

Sponsors and collaborators