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Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication (CURB)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Balloon atrial septostomy
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 Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, balloon atrial septostomy, radiofrequency catheter ablation, spontaneous closure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Idiopathic severe pulmonary arterial hypertension;
  2. Severe pulmonary arterial hypertension associated with repaired congenital heart disease;
  3. World Health Organization functional class III or IV with right heart failure refractory to medical therapy;
  4. Severe syncopal symptoms;

Exclusion Criteria:

  1. Mean right atrial pressure >20 mm Hg;
  2. Room-air resting arterial oxygen saturation <85%;
  3. Left ventricular end diastolic pressure (LVEDP) >18mm Hg;
  4. Pulmonary vascular resistance >55 wood units/m2.
  5. Severe right ventricular failure on cardio-respiratory support
  6. The predicted one-year survival <40%;

Sites / Locations

  • National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

control group

single-RFA group

double-RFA group

Arm Description

Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.

After graded balloon atrial septostomy procedure identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration.

The first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (graded balloon atrial septostomy and radiofrequency catheter ablation around the rim of fenestration).

Outcomes

Primary Outcome Measures

The size change of the fenestration created with atrial septostomy
The changes of the fenestration-size will be followed up in three different groups

Secondary Outcome Measures

The exercise tolerance
6-min walk test
The systemic arterial oxygen saturation
The change of systemic arterial oxygen saturation after atrial septostomy
World Health Organization functional class
World Health Organization functional class before and after atrial septostomy

Full Information

First Posted
May 31, 2018
Last Updated
November 11, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03554330
Brief Title
Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication
Acronym
CURB
Official Title
The Combined Use of Radiofrequency-catheter-ablation and Balloon-atrial-septostomy (CURB) in the Creation of a Stable Inter-atrial Communication:a Preliminary Study in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (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

5. Study Description

Brief Summary
Though graded balloon-atrial-septostomy (BAS) has been accepted as an effective palliative therapy for severe pulmonary arterial hypertension, spontaneous closure of septostomy is not uncommon. Radiofrequency-catheter-ablation (RFA), which has the potential to cause irreversible damage around the rim of created inter-atrial communication, might contribute to prevent the spontaneous closure. In patients with severe pulmonary arterial hypertension, the combined use of RFA and BAS (CURB) is investigated to create a stable inter-atrial communication.
Detailed Description
Balloon atrial septostomy (BAS) is an important palliative therapy in patients with refractory pulmonary arterial hypertension. However, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. 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. In this study, the patients between 18 and 60 years of age who have severe pulmonary arterial hypertension associated with right heart failure refractory to medical therapy or severe syncopal symptoms may be eligible for this study (idiopathic severe pulmonary arterial hypertension or severe pulmonary arterial hypertension associated with repaired congenital heart disease). These patients will be randomized 1:1:1 to control group, single-RFA group and double-RFA group: In control group: only BAS is carried out. In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration. In double-RFA group: the first step is RFA on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration). The immediate size of created fenestration will be determined with intra-cardiac echocardiography, and 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 exercise tolerance, cardiac index, systemic arterial oxygen saturation and so on.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, balloon atrial septostomy, radiofrequency catheter ablation, spontaneous closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.
Arm Title
single-RFA group
Arm Type
Experimental
Arm Description
After graded balloon atrial septostomy procedure identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration.
Arm Title
double-RFA group
Arm Type
Experimental
Arm Description
The first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (graded balloon atrial septostomy and radiofrequency catheter ablation around the rim of fenestration).
Intervention Type
Other
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
(1) In control group: only graded balloon atrial septostomy will be carried out and there is no radiofrequency catheter ablation. (2) In single-RFA group: after graded balloon atrial septostomy identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration. (3) In double-RFA group: the first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration).
Intervention Type
Other
Intervention Name(s)
Balloon atrial septostomy
Intervention Description
Graded balloon atrial septostomy is performed in all patients.
Primary Outcome Measure Information:
Title
The size change of the fenestration created with atrial septostomy
Description
The changes of the fenestration-size will be followed up in three different groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The exercise tolerance
Description
6-min walk test
Time Frame
12 months
Title
The systemic arterial oxygen saturation
Description
The change of systemic arterial oxygen saturation after atrial septostomy
Time Frame
12 months
Title
World Health Organization functional class
Description
World Health Organization functional class before and after atrial septostomy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic severe pulmonary arterial hypertension; Severe pulmonary arterial hypertension associated with repaired congenital heart disease; World Health Organization functional class III or IV with right heart failure refractory to medical therapy; Severe syncopal symptoms; Exclusion Criteria: Mean right atrial pressure >20 mm Hg; Room-air resting arterial oxygen saturation <85%; Left ventricular end diastolic pressure (LVEDP) >18mm Hg; Pulmonary vascular resistance >55 wood units/m2. Severe right ventricular failure on cardio-respiratory support The predicted one-year survival <40%;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaowu Yan, PhD and MD
Phone
+8610-88322265
Email
chaowuyan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaowu Yan, PhD and MD
Organizational Affiliation
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaowu Yan, PhD and MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35676068
Citation
Yan C, Wan L, Li H, Wang C, Guo T, Niu H, Li S, Yundan P, Wang L, Fang W. First in-human modified atrial septostomy combining radiofrequency ablation and balloon dilation. Heart. 2022 Oct 13;108(21):1690-1698. doi: 10.1136/heartjnl-2022-321212.
Results Reference
result
PubMed Identifier
36329641
Citation
Yan C. Is combined use of radiofrequency ablation and balloon dilation the future of interatrial communications? Expert Rev Cardiovasc Ther. 2022 Nov;20(11):895-903. doi: 10.1080/14779072.2022.2144233. Epub 2022 Nov 10.
Results Reference
result

Learn more about this trial

Combined Use of Radiofrequency-ablation and Balloon-septostomy in the Creation of a Stable Inter-atrial Communication

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