The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— AFR-Prophet  

Official title:

Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022851
• Other study ID #: Occ2016_04
• Secondary ID: CIV-16-07-016324
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Occlutech International AB
• Contact: Gönül Sönmez Utkun
• Phone: +902124650497
• Email: clinicaltrials[@]occlutech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with severe pulmonary hypertension (PH).

Description:

This study will enroll subjects with severe pulmonary hypertension until a maximum of 30 patients have undergone implantation with the Occlutech® AFR device. Enrolment will be devided in 2 phases.

Phase 1: At least 15 adult patients with age ≥ 18 years will be enrolled. Phase 2: Patients with age ≥ 6 years will be enrolled until a maximum of 30 patients is reached.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age is = 18 / =6 years (phase 1 / phase 2).

2. Patient consents to participation

3. The patient or his/her legal representative should have the ability to fluently speak and under-stand the language in which the study is being conducted. If the patient speaks a different language, then a sentence-to-sentence translation for unequivocal understanding must be provided.

4. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

5. Patient agrees to comply with the follow-up schedule.

6. Patient has had a successful BAS procedure and is in a stable hemodynamic state, as assessed by the investigator.

7. Conventional treatment options for the patient are exhausted according to ESC and AHA guidelines.

8. SpO2> 86 % pulsoxymetric measurement) This document is confidential and property of Occlutech. It´s only for clinical personnel, Ethical committees and third person in direct contact with the clinical responsible. It is not allowed to distribute information contained in this document without the permission of Occlutech unless the information is already published.

9. "Syncope"(Group A-PH) 9.1. Syncope due to acute PH episodes (as defined by exclusion of other causes) 9.2. Other causes of syncope must have been actively excluded 9.3. Syncope (Black-out) or pre-syncope (episodic dizziness) >2 last 3 months 9.4. PH (defined as mean pulmonary artery pressure > 25 mmHg, or pulmonary vascular resistance of > 3 Wood Units) must exist, RV-failure is however not a prerequisite

10. "RV-Failure"(Group B-PH) 10.1. Right heart failure, chronic and clinically severe 10.1.1.NYHA class III or worse 10.1.2. 6 min walk < 320 m 10.1.3. Signs of venous congestion (distended veins, edema, ascites, etc) 10.1.4.Symptomatic disease resulting in 1 or more PH-related hospitalization over the last 12 months. Elective hospital admissions solely for the purpose of performing diagnostic procedures do not count for this.

10.2. Severe pulmonary hypertension as evident by echocardiography Echocardiographic:

10.2.1. RV larger than LV; 10.2.2. RA larger than LA; 10.2.3. atrial septum bulging into left atrium 10.2.4.ventricular septum bulging into the left ventricle 10.2.5.Reduced (below age-related normal mean value) TAPSE 10.3. Severe pulmonary hypertension as evident by CATH CATH-data: 10.3.1.Mean RA pressure (RAP) of > 10 and = 20 mmHg; 10.3.2.Mean LA pressure (LAP) < 15 mmHg 10.3.3.Mean RAP > mean LAP; 10.3.4.Mean pulmonary arterial pressure >25 mm Hg 10.3.5. Echocardiographically demonstrated continuous right to left shunt following balloon aterial septostomy (BAS) and before AFR device implantation.

Exclusion Criteria

Processes which interfere medically with invasive device implantation

1. Local or generalized sepsis or other acute infection(s)

2. Thrombophilic coagulation disorder

3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials

4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy

5. Intolerance to contrast agents

6. Participation in other medical trials shorter than 30 days before the intended AFR implantation procedure

7. Pregnancy - (assessed in patients with child bearing potential by urine dip stick)

8. Any intracardiac intervention within the last 30 days

9. Thickness of atrial septum > 12mm OR Processes which would technically disturb the safe intervention as planned

1. Occluded inferior vena cava access 2. Previous ASD/PFO closure device in place 3. Intracardiac thrombus OR any other circumstance that, in the opinion of the Investigator,

might interfere with the implantation, might affect the patient's well-being thereafter or might interfere with the conduct and follow up within the Study is general.

Exclusion Criteria:

• Local or generalized sepsis or other acute infection(s)

• Thrombophilic coagulation disorder

• Allergy to nickel and/or titanium and/or nickel/titanium-based materials

• Allergy to anti-platelet, -coagulant, or -thrombotic therapy

• Intolerance to contrast agents

• Participation in other medical trials shorter than 30 days before the intended AFR implantation procedure

• Pregnancy

• Any intracardiac intervention within the last 30 days

• Occluded inferior vena cava access

• Previous ASD/PFO closure device in place

• Intracardiac thrombus

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Occlutech AFR Device
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.

Locations

Country	Name	City	State
Germany	Elisabeth Krankenhaus	Essen
Germany	Justus-Liebig Universität	Giesen
Germany	Klinikum der Universität München	Munich	Bavaria
Germany	Universitätsklinikum Würzburg	Würzburg
Netherlands	University of Groningen	Groningen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Gdanski Uniwersytet Medyczny	Gdansk
Poland	Uniwersytet Jagiellonski Collegium Medicum	Kraków
Poland	Szpital im. Fryderyka Chopina	Otwock
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego	Poznan
Turkey	Hacettepe Üniversitesi Tip Fakültesi	Altindag
Turkey	Ankara Diskapi Yildirim Beyazit Hastanesi	Ankara
Turkey	Kartal Kosuyolu Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Ege Üniversitesi Tip Fakültesi Hastanesi	Izmir
Turkey	Saglik Bilimleri Üniversitesi Tepecik Egitim ve Arastirma Hastanesi	Izmir
Turkey	Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi	Kocaeli
Turkey	Sivas Cumhuriyet Üniversitesi Tip Fakültesi	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Germany,  Netherlands,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations.	To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.	0-3 month
Secondary	Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation	To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.	3-12 month
Secondary	Evidence of a secure placement of the device and of right-to-left shunt through the AFR device immediately after implantation and 3 month and 12 month after procedure.	The secondary efficacy endpoint will be determined via assessment by color-doppler echocardiography and angiography/fluoroscopy and requires both of: Device placed in situ [as assessed by the investigator] Evidence of RIGHT TO LEFT shunt through the AFR device [as assessed by the investigator]	0-12 month
Secondary	Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation		0-12 month