Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

Heart Failure With Normal Ejection Fraction Clinical Trial

— FROST-HF  

Official title:

Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03751748
• Other study ID #: AC201809
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2018
• Source: St. Michael's Hospital, Toronto
• Contact: Asim Cheema, MD, PhD
• Phone: 416-864-5739
• Email: cheemaa[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

Description:

The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: April 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Age > 40 years

• LVEF > 45% documented within the last 3 months.

• NYHA class =II status or 6MWT distance <80% predicted.

• Left atrial enlargement

• PCWP =25 mmHg during supine bicycle exercise on hemodynamic monitoring.

• Left atrial pressure greater than right atrial pressure by =5 mmHg on hemodynamic monitoring.

Exclusion Criteria:

• Recent MI, PCI or CABG

• Untreated CAD with indication for revascularization

• Recent stroke, pulmonary embolism or major surgery

• Uncontrolled atrial fibrillation

• H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease

• Inability to perform a 6-minute walk test.

• Clinically significant valvular disease

• Uunsuitable for study participation at investigator discretion.

• Severe COPD, Anemia or morbid obesity

• Uncontrolled hypertension

• Women of child bearing age

• RA pressure >15 mmHg or PVR >4 wood units

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction

Intervention

Device:
• AFR implantation
Implantation of atrial flow regulator (AFR) device
• Sham procedure
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo

Locations

Country	Name	City	State
Canada	Sinai Health System	Toronto	Ontario
Canada	St. Michael's hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Sinai Health System, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	Six minute walk test at 12 months	12 months
Secondary	MACE	Composite of cardiac death, heart failure hospitalization and worsening heart failure	12 months
Secondary	Cardiac death	Death from a cardiac cause (myocardial infarction, sudden death)	12 months
Secondary	Congestive heart failure (CHF)	Heart failure hospitalization, worsening heart failure	12 months
Secondary	Quality of Life (QOL)	QOL as per KCCQE questionaire	12 months