RecruitingNot Applicable

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

France150 participantsStarted 2020-10-28

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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\*
✓. LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF)
✓. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent

✕. 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
✕. Evidence of right heart failure defined (by ECHO) as:
✕. Severe Right Ventricular Dysfunction (TAPSE \< 14 mm)
✕. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
✕. Severe pulmonary hypertension (PASP \> 60 mm Hg)
✕. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
✕. Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
✕. Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy

Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation.

Timeframe: 1 year

NCT IDNCT04405583

SponsorOcclutech International AB

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-06-30

Gönül Sonmez Utkun

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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\*
✓. LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF)
✓. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent

✕. 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
✕. Evidence of right heart failure defined (by ECHO) as:
✕. Severe Right Ventricular Dysfunction (TAPSE \< 14 mm)
✕. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
✕. Severe pulmonary hypertension (PASP \> 60 mm Hg)
✕. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
✕. Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
✕. Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy