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Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (4)

The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)
12 months
Change of PAWP or MLAP at rest
12 months
Change of cardiac remodeling
12 months
Myocardial remodeling
12 months

Interventions

Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilationProcedure

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.

CURB procedure

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Related Publications (1)

Yan C, Li H, Wan L, Liu A, Yundan P, Guo T, Hua L, Wang L, Fang W. Left atrial pressure normalisation by graded radiofrequency atrial septostomy in heart failure with preserved ejection fraction: a single-arm pilot study. Heart. 2025 Oct 14;111(21):1020-1027. doi: 10.1136/heartjnl-2025-325929.

PMID: 40425275DERIVED

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: 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.

Sponsor Type

OTHER GOV

Responsible Party

SPONSOR

Personalized Atrial Septostomy for Heart Failure

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

CURB procedure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

CURB procedure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations