Technology | Heart Failure | May 07, 2018

Minnesota Living With Heart Failure Questionnaire Qualified for FDA Medical Device Development Tools Program

FDA rules 21-question assessment is viable method for manufacturers and clinical trial sponsors to determine effectiveness of heart failure treatments

Minnesota Living With Heart Failure Questionnaire Qualified for FDA Medical Device Development Tools Program

The CORolla device from Israel-based CorAssist is one example of new devices being manufactured and tested to treat heart failure. The efficacy of this and other new devices under development can now be assessed with the Minnesota Living With Heart Failure Questionnaire. 

May 7, 2018 — The U.S. Food and Drug Administration (FDA) has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of the Medical Device Development Tools (MDDT) program. This voluntary program is intended to reduce regulatory burden for medical device developers and FDA reviewers by qualifying tools that can aid in the development and evaluation of medical devices. Tools qualified by the FDA can be used by the medical device industry to support device submissions, which could reduce time and resources involved in product development.

The Minnesota Living with Heart Failure Questionnaire is comprised of 21 self-administered questions designed to measure the adverse effects of heart failure on patients’ lives. The patient receives a brief set of instructions, and then uses a scale from zero to five to indicate how much each dimension of heart failure has affected their life over the previous four weeks. The questionnaire asks patients to rate the following dimensions of quality of life:

1) Physical symptoms and signs of heart failure;

2) Common physical/social functions;

3) Psychosocial and cognitive function; and

4) Overall adverse impact on quality of life.

The questionnaire can be used to determine whether a device is effectively treating or improving patients’ quality of life by reducing the adverse impact of heart failure. The instrument can be used as a secondary endpoint in feasibility and pivotal studies of outpatients with symptomatic (New York Heart Association class II and III) heart failure. The questionnaire may be used by medical device companies and sponsor-investigators in controlled clinical trials designed to test superiority or non-inferiority of medical devices in support of regulatory submissions.

When used within the qualified context of use, manufacturers and sponsors do not have to justify their use of the tool, and FDA review staff can accept the use of the tool without the need to reconfirm its suitability and utility.

FDA qualification of a medical device development tool is different from FDA clearance or approval of a medical device. The type of evidence needed to support qualification is not the type of evidence that is needed to support marketing authorization for a medical device.

More information about the Minnesota Living with Heart Failure Questionnaire, including how to access the tool, is available in the Summary of Evidence and Basis for Qualification. More information about the medical device development tools program is available on the FDA’s Medical Device Development Tools webpage. Additional tools will be added to the webpage once they are qualified.

For more information: www.fda.gov

 

Related Content

Examples of  allogeneic cardiac cells (also called cardiosphere-derived cells or CDCs).

Examples of allogeneic cardiac cells (also called cardiosphere-derived cells or CDCs), that were used to treat heart attack infarcts to reverse heart failure in the ALLSTAR trial.

News | Heart Failure | August 04, 2020
August 4, 2020 - More than three years after a clinical trial was prematurely ended for failing to show progress in h
News | Heart Failure | July 09, 2020
July 9, 2020 – The Minneapolis Heart Institute Foundation (MHIF) is conducting additional research on a novel hydroge
Navin Kapur, M.D., Tufts Medical Center, shows preCardia device and its anatomical positioning in the patient to treat heart failure..

Navin Kapur, M.D., Tufts Medical Center, shows preCardia device and its anatomical positioning in the patient.

News | Heart Failure | June 23, 2020
June 23, 2020 — The U.S.
Patients with worsening heart failure and reduced ejection fraction who received the investigational drug vericiguat had a significantly lower rate of cardiovascular death or heart failure hospitalization compared with those receiving a placebo, based on research presented at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) #ACC20/#WCCardio
News | Heart Failure | March 29, 2020
March 29, 2020 — Patients with worsening heart failure and reduced ejection fraction who received the investigational
Dapagliflozin Reduces Heart Failure Worsening and Death in DAPA-HF Sub-analysis. #ACC20 #ACC2020
News | Heart Failure | March 28, 2020
March 28, 2020 — New data from a sub-analysis of the landmark Phase III...
News | Heart Failure | March 05, 2020
March 5, 2020 — Abbott recently received Breakthrough Device designation from the U.S.
Some of the new devices technologies to treat heart failure that are either in clinical trials or were recently cleared by the U.S. FDA. #heartfailure

Some of the new devices technologies to treat heart failure that are either in clinical trials or were recently cleared by the U.S. FDA. 

Feature | Heart Failure | February 21, 2020 | Dave Fornell, Editor
There are several new tools being added to the clinical armamentarium in the fight against...
Tufts Medical Center created a heart failure team approach to care for its patients. The program includes an interventional heart failure fellowship program, where interventional cardiologists learn more advanced care, as show here with an ECMO procedure being performed in a cath lab at Tufts. The interventional cardiologists learn how to better care for heart failure patients and interface with surgeons, intensivists and others on the HF care team. The operator is Nevin Kapur. Photo by Dave Fornell.

Tufts Medical Center created a heart failure team approach to care for its patients. The program includes an interventional heart failure fellowship program, where interventional cardiologists learn more advanced hemodynamic support methods, as shown here with an ECMO procedure being performed in a cath lab at Tufts. The interventional cardiologists learn how to better care for heart failure patients and interface with surgeons, intensivists and others on the HF care team. Photo by Dave Fornell.

Feature | Heart Failure | February 20, 2020 | Dave Fornell, Editor
There is no, single magic bullet in heart failure (HF) to easily reduce readmission rates or easily reverse this...