Personalized Atrial Septostomy for Heart Failure

NCT04573166 | Unknown DMC

• 1 other identifier: 2020-8
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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).

Conditions

Heart Failure; Heart Failure, Diastolic

Keywords

Heart failure; atrial septostomy

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

Study Arms (1)

CURB procedure

EXPERIMENTAL

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

Procedure: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

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

Beijing, Beijing Municipality, 100037, China

Location

Yan Chaowu

Beijing, Beijing Municipality, 100037, China

Location

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: 40425275 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Chaowu Yan, PhD and MD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

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

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.

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: October 5, 2020
• Study Start: September 25, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)