Flow Regulation by Opening the Septum in Patients With He... | NCT03751748

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

NCT03751748

Sponsor

Unity Health Toronto

Status

Unknown status

Last Update Posted

Nov 23, 2018Actual

Enrollment

230Estimated

Phase

Not Applicable

Conditions

Heart Failure With Normal Ejection Fraction

Interventions

AFR implantation
Sham procedure

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Nov 14, 2018

First Submission Date that Met QC Criteria

Nov 21, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2018

Last Update Posted Date

Nov 23, 2018Actual

Name	Class
Sinai Health System	OTHER
University Health Network, Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control arm	Sham Comparator	Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo	Device: Sham procedure
AFR arm	Experimental	Implantation of Occlutech atrial flow regulator (AFR) device	Device: AFR implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AFR implantation	Device	Implantation of atrial flow regulator (AFR) device	AFR arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6MWT	Six minute walk test at 12 months	12 months

Secondary Outcomes

Measure	Description	Time Frame
MACE	Composite of cardiac death, heart failure hospitalization and worsening heart failure	12 months
Cardiac death	Death from a cardiac cause (myocardial infarction, sudden death)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asim Cheema, MD, PhD	Contact	416-864-5739		cheemaa@smh.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's hospital		Toronto	Ontario	M5B 1W8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided