FreeFlow Percutaneous Atrial Septal Shunt for IPAH

NCT06605794 | Recruiting DMC

• 1 other identifier: 2023-111R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are:

• Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension?
• Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy. Participants will:
• underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation.
• will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• All-cause mortality at 6 months

  All-cause mortality at 6 months

  6 months

• Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension

  Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months

  6 months

Secondary Outcomes (9)

• Effective shunt rate at the end point

  12 months

• Shunt Success rate

  12 months

• The WHO functional class was changed 12 months after operation

  12 months

• Changes in NT-pro BNP at 12 months after surgery

  12 months

• The change of exercise capacity (6min walking test) was observed 12 months after operation

  12 months

Study Arms (1)

Device-intervention Group

EXPERIMENTAL

FreeFlow percutaneous atrial septal shunt

Device: FreeFlow percutaneous atrial septal shunt

Interventions

FreeFlow percutaneous atrial septal shunt DEVICE

The trial devices included a percutaneous atrial septal shunt and an atrial septal shunt delivery system. The specifications of the atrial septal shunt device were -φ5, φ7, φ9, φ11, and the specifications of the atrial septal shunt delivery system-FFISS-B were 9F and 10F.

Device-intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤70 years old, female or male;
• mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
• The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg);
• WHO grade III or IV;
• NT-proBNP≥650 ng/L;
• The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up.

You may not qualify if:

• Local or systemic sepsis or other acute infection;
• Severe coagulopathy;
• Allergy to nickel and/or titanium and/or nickel/titanium-based materials;
• Patients with contraindications to antiplatelet, coagulant or thrombotic therapy;
• Intolerance to contrast media;
• Have participated in other drug or device clinical trials during the same period;
• Glomerular filtration rate (GFR) \< 50 mL/min;
• Patients with severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal);
• The patient had malignant arrhythmia;
• The patient did not receive standardized drug therapy (triple sequential therapy) according to the Chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months;
• Women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding;
• Severe restrictive or obstructive lung disease;
• Implanted atrial septal defect (ASD)/ patent foramen ovale (PFO) closure device;
• Left ventricular ejection fraction (LVEF) \<50%;
• SpO2 \< 90% without oxygen inhalation (pulse measurement);

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Junbo GE, Prof.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daxin ZHOU, Prof.

CONTACT

13801641252; zhou.daxin@zs-hospital.sh.cn

Dandan CHEN, Prof.

CONTACT

13788926105; chen.dandan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 20, 2024
• Study Start: September 11, 2023
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

CN (1)