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Personalized Atrial Septostomy for Heart Failure (PAS)

Primary Purpose

Heart Failure, Heart Failure, Diastolic

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure; atrial septostomy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years;
  2. Symptomatic heart failure in NYHA class III or IV ambulatory;
  3. Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;
  4. LVEF ≥ 45%;
  5. Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;
  6. LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg;
  7. Systolic blood pressure ≥ 90 mmHg.

Exclusion Criteria:

  1. Acute infection or sepsis;
  2. Intra-cardiac mass, thrombus or vegetation;
  3. Evidence of right heart failure (TAPSE < 14 mm);
  4. Pulmonary hypertension (PASP > 60 mmHg);
  5. Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;
  6. TIA or stroke within the last 6 months;
  7. Thromboembolic events within the last 6 months;
  8. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure;
  9. Valvular diseases requiring therapy according to current ESC guidelines;
  10. Life expectancy < 1 year for non-cardiovascular reasons.

Sites / Locations

  • National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
  • Yan Chaowu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CURB procedure

Arm Description

Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)

Outcomes

Primary Outcome Measures

Clinical change
Distance in 6 minutes walk test
The size of created-fenestration
The change of created-fenestration size evaluated with echocardiography

Secondary Outcome Measures

The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)
Peri-procedural, and 12 months MACCE and systemic embolic events in patients after CURB procedure.
Change of PAWP or MLAP at rest
Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization
Change of cardiac remodeling
The change in cardiac chamber and function evaluated with MSCT and CMR
Myocardial remodeling
The myocardial molecular imaging evaluated with PET-CT

Full Information

First Posted
September 20, 2020
Last Updated
April 2, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT04573166
Brief Title
Personalized Atrial Septostomy for Heart Failure
Acronym
PAS
Official Title
Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
Detailed Description
Atrial septostomy is an important palliative therapy in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) . Though the safety of balloon atrial septostomy (BAS) is satisfactory, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. The device-implantation improves the long-term patency. However, the created fenestration is limited with fixed size and it is further complicated with the potential device-related complications. Radiofrequency catheter ablation (RFA) has the potential to cause irreversible damage around the rim of fenestration created with BAS, which might prevent the re-adhesion of the septal remnants. In addition, RFA on fossae ovalis might reduce the elastic recoil of local tissue and contribute to create larger inter-atrial fenestration with same BAS procedure. Therefore, the combined use of radiofrequency-ablation and balloon-dilation (CURB) might become a novel procedure to create a stable inter-atrial fenestration. In this study, the adult patients who have HFrEF and HFpEF refractory to medical therapy may be eligible for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure, Diastolic
Keywords
Heart failure; atrial septostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the levels of AOP and MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 12 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CURB procedure
Arm Type
Experimental
Arm Description
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)
Intervention Type
Procedure
Intervention Name(s)
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation
Intervention Description
After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the level of MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 6 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
Primary Outcome Measure Information:
Title
Clinical change
Description
Distance in 6 minutes walk test
Time Frame
12 months
Title
The size of created-fenestration
Description
The change of created-fenestration size evaluated with echocardiography
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)
Description
Peri-procedural, and 12 months MACCE and systemic embolic events in patients after CURB procedure.
Time Frame
12 months
Title
Change of PAWP or MLAP at rest
Description
Pulmonary capillary wedge pressure (PCWP)/MLAP at rest evaluated with right heart catheterization
Time Frame
12 months
Title
Change of cardiac remodeling
Description
The change in cardiac chamber and function evaluated with MSCT and CMR
Time Frame
12 months
Title
Myocardial remodeling
Description
The myocardial molecular imaging evaluated with PET-CT
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Symptomatic heart failure in NYHA class III or IV ambulatory; Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months; LVEF ≥ 45%; Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest; LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg; Systolic blood pressure ≥ 90 mmHg. Exclusion Criteria: Acute infection or sepsis; Intra-cardiac mass, thrombus or vegetation; Evidence of right heart failure (TAPSE < 14 mm); Pulmonary hypertension (PASP > 60 mmHg); Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest; TIA or stroke within the last 6 months; Thromboembolic events within the last 6 months; Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure; Valvular diseases requiring therapy according to current ESC guidelines; Life expectancy < 1 year for non-cardiovascular reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaowu Yan, PhD and MD
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Yan Chaowu
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Atrial Septostomy for Heart Failure

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