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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022851
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

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

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Device: Occlutech AFR Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Occlutech AFR Device
Patients who will get the AFR Device implantation
Device: Occlutech AFR Device
Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.




Primary Outcome Measures :
  1. Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations. [ Time Frame: 0-3 month ]

Secondary Outcome Measures :
  1. Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation [ Time Frame: 3-12 month ]
  2. 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. [ Time Frame: 0-12 month ]

    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]


  3. Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation [ Time Frame: 0-12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age is ≥ 18
  • Patient consents to participation
  • Patient has had a successful ballon atrial septostomy (BAS)- procedure and is in a stable hemodynamic state
  • Conventional treatment options for the patient are exhausted according to ESC- (European Society of Cardiology) and AHA (American Heart Association) -guidelines.
  • Syncope due to acute Pulmonary Hypertension episodes
  • Other causes of syncope must have been actively excluded
  • Syncope or pre-syncope >2 last 3 months
  • PH (Pulmonary artery pressure (PAP) > 25 mmHg, or pulmonary vascular resistance of > 3 Wood Units)
  • Right heart failure, chronic and clinically severe
  • Severe pulmonary hypertension as evident by echocardiography or catheterisation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022851


Contacts
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Contact: Thomas Schöndorf +49(0)3641 67 51 20 clinicaltrials@occlutech.com

Locations
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Germany
Klinikum der Universität München Recruiting
Munich, Bavaria, Germany, 81377
Contact: Nikolaus Haas, Prof.         
Sponsors and Collaborators
Occlutech International AB

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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT03022851    
Other Study ID Numbers: Occ2016_04
CIV-16-07-016324 ( Other Identifier: EUDAMED )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases