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

November 11, 2022 updated by: China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. In control group: only BAS is carried out.
  2. In single-RFA group: after BAS procedure identical to control group, RFA is performed immediately around the rim of created inter-atrial fenestration.
  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: control group
Only graded balloon atrial septostomy is carried out, and no radiofrequency catheter ablation is performed.
Other: Balloon atrial septostomy
Graded balloon atrial septostomy is performed in all patients.
EXPERIMENTAL: single-RFA group
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.
Other: Balloon atrial septostomy
Graded balloon atrial septostomy is performed in all patients.
Other: Radiofrequency catheter ablation
(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).
EXPERIMENTAL: 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 (graded balloon atrial septostomy and radiofrequency catheter ablation around the rim of fenestration).
Other: Balloon atrial septostomy
Graded balloon atrial septostomy is performed in all patients.
Other: Radiofrequency catheter ablation
(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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The size change of the fenestration created with atrial septostomy
Time Frame: 12 months
The changes of the fenestration-size will be followed up in three different groups
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The exercise tolerance
Time Frame: 12 months
6-min walk test
12 months
The systemic arterial oxygen saturation
Time Frame: 12 months
The change of systemic arterial oxygen saturation after atrial septostomy
12 months
World Health Organization functional class
Time Frame: 12 months
World Health Organization functional class before and after atrial septostomy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Chaowu Yan, PhD and MD, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2018

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (ACTUAL)

June 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-GZ15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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