Atrial Flow Regulator in Heart Failure (PROLONGER)

Pomeranian atRial flOw reguLatOr iN conGestive hEart failuRe (PROLONGER) Trial

The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.

Study Overview

• Status: Unknown
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: Atrial flow regulator (Occlutech® AFR device)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukasz Lewicki, MD, PhD; Phone Number: +48501702885; Email: luklewicki@gmail.com
• Study Contact Backup: Name: Maciej Karwowski, MD; Phone Number: +48500473983; Email: maciejkarwowskimd@gmail.com

Study Locations

• Poland
  • Wejherowo, Poland, 84-200
    • Recruiting
    • Kashubian Cardiovascular Center
    • Contact: Maciej Karwowski, MD; Phone Number: +48500473983; Email: maciejkarwowskimd@gmail.com
    • Contact: Lukasz Lewicki, MD,PhD; Phone Number: +48501702885; Email: luklewicki@gmail.com
    • Principal Investigator: Lukasz Lewicki, MD,PhD
    • Sub-Investigator: Maciej Karwowski, MD
    • Sub-Investigator: Sebastian Liedtke, MD
    • Sub-Investigator: Katarzyna Kosmalska, MD,PhD
    • Sub-Investigator: Marek Szolkiewicz, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Symptomatic heart failure (HF) in NYHA class III or IV ambulatory
• Optimal medical therapy of HF according to European Society of Cardiology (ESC) guidelines for last 6 months
• Hospitalization because of HF decompensation in last 12 months
• Absence of significant valvular disease requiring cardiac surgery
• Life expectancy ≥ 1 year
• Written informed consent obtained from the patient
• Left ventricle ejection fraction (LVEF) ≥ 15%

• Elevated left heart filling pressures:

  1. Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or
  2. PAWP > 25 mmHg during hand grip test

Exclusion Criteria:

• Participation in another clinical trial in last 30 days
• Acute infection or sepsis
• Severe coagulation disorder
• Allergy to nickel or titanium
• Severe peripheral artery disease disabling 6 minutes walk test
• Allergy to antiplatelet drugs, oral anticoagulants or heparin
• Contraindication to trans-oesophageal echocardiography (TEE)
• Pregnancy
• Atrial septal defect (ASD) or presence of atrial septal occluder
• Severe patent foramen ovale (PFO) with significant left to right shunt in rest
• Intracardiac thrombus
• Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) in last 6 months

• Severe pulmonary hypertension:

  1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)
  2. Right atrial pressure > 20 mmHg (measured in right heart catheterization)
• Planned heart transplantation
• Transient ischemic attack or stroke within last 6 months
• Cardiac resynchronisation therapy (CRT) within last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Atrial flow regulator; In this arm, patients who have elevated left ventricle filling pressures get (Occlutech® AFR device) and optimal therapy for Heart failure (HF).	Device: Atrial flow regulator (Occlutech® AFR device); Atrial septostomy followed by implantation of AFR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	Increase in 6 minutes walk test distance	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement II	Reduction in New York Heart Association (NYHA) class	12 months
Device related adverse event	Device migration, embolization, device related thrombus, shunt occlusion, need for device removal	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary artery wedge pressure (PAWP) at rest	Reduction of PAWP at rest	30 days after AFR
Pulmonary artery wedge pressure (PAWP) during handgrip test	Reduction of PAWP during handgrip test	30 days after AFR
KCCQ-12	Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	12 months
Clinical adverse event	Cardiac mortality	12 months
Clinical adverse event II	Rehospitalization for HF decompensation	12 months

Collaborators and Investigators

• Sponsor: Szpitale Pomorskie Sp. z o. o.
• Investigators: Principal Investigator: Lukasz Lewicki, MD,PhD, Kashubian Cardiovascular Center; University Center for Cardiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: atrial flow regulator; heart failure; interatrial shunting
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 01/2020/W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The following data will be available:

• echocardiography reports
• right heart catheterization reports
• clinical and demographic data

• IPD Sharing Time Frame: The data will be available after completion of the study.
• IPD Sharing Access Criteria: The data will be shared on personal request for review process.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No