Atrial Flow Regulator in Heart Failure

Congestive Heart Failure Clinical Trial

— PROLONGER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334694
• Other study ID #: 01/2020/W
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: January 2022

Study information

• Verified date: April 2020
• Source: Szpitale Pomorskie Sp. z o. o.
• Contact: Lukasz Lewicki, MD, PhD
• Phone: +48501702885
• Email: luklewicki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Atrial flow regulator (Occlutech® AFR device)
Atrial septostomy followed by implantation of AFR.

Locations

Country	Name	City	State
Poland	Kashubian Cardiovascular Center	Wejherowo

Sponsors (1)

Lead Sponsor	Collaborator
Szpitale Pomorskie Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulmonary artery wedge pressure (PAWP) at rest	Reduction of PAWP at rest	30 days after AFR
Other	Pulmonary artery wedge pressure (PAWP) during handgrip test	Reduction of PAWP during handgrip test	30 days after AFR
Other	KCCQ-12	Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	12 months
Other	Clinical adverse event	Cardiac mortality	12 months
Other	Clinical adverse event II	Rehospitalization for HF decompensation	12 months
Primary	Clinical improvement	Increase in 6 minutes walk test distance	12 months
Secondary	Clinical improvement II	Reduction in New York Heart Association (NYHA) class	12 months
Secondary	Device related adverse event	Device migration, embolization, device related thrombus, shunt occlusion, need for device removal	12 months