Condition category
Circulatory System
Date applied
29/08/2019
Date assigned
18/09/2019
Last edited
18/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients whose doctors recommend that the patient be implanted with a market-released Cardiac Resynchronization Therapy (CRT) device to correct heart failure are being studied. The purpose of a CRT device is to restore natural electrical rhythm (called resychronization). Resynchronization is normally delivered using a lead in the left heart and a lead in the right heart connected to a CRT device. In this study, a potential method is being evaluated to provide ideal cardiac resynchronization using an investigational system, called the VFAHF system. The purpose of this study is to collect data to evaluate safety and resynchronization capabilities of the VFAHF Research System.

Who can participate?
Patients who have Heart Failure and meet other inclusion/exclusion criteria.

What does the study involve?
Before study patients are implanted with a market-released (approved) CRT device, they will first be temporarily implanted with a lead the right heart. Images will be taken of the heart and the placement of the lead during the implant procedure, using echocardiography (imaging of the heart using sound waves) or fluoroscopy (which uses X-ray images on a monitor similar to an X-ray movie). During these implant procedures, heart rhythm will be monitored using a Medtronic Electrocardiogram (ECG) Belt Research System. After these measurements and images are taken, the temporary lead will be removed and CRT implant will proceed normally. Patients will also have a follow-up visit one month after their implant, to assess for medication changes and adverse events.

What are the possible benefits and risks of participating?
Patients may not have any direct medical benefits. The information from this study may benefit other subjects with heart failure in the future.

The potential risks associated with participating in the VFAHF study are similar to normal CRT implant risks but may increase some risks. These potential risks may include, but are but are not limited to, the following:
1. Increased risk of infection
2. Increased risk of embolus (a clot that travels through the bloodstream)
3. Increased risk of hematoma (bruise)
4. Pneumothorax (abnormal accumulation of air in the space between the chest wall and lung causing a collapsed lung)
5. Hemothorax (abnormal accumulation of blood in the space between the chest wall and lung)
6. Increased risk of cardiac perforation (puncture of the heart)
7. Increased risk of cardiac tamponade (blood or fluid in the space between the sac around the heart and the heart muscle)
8. Increased risk of cardiac arrest (when the heart stops pumping blood)
9. Lethargy (a lack of energy and enthusiasm)
10. Dizziness
11. Rapid or irregular heartbeats/heart rhythms
12. Increased risk of tissue damage, inflammation, or fibrillation due to electrical currents and/or leads introduced into the heart
13. Valve dysfunction (when a flap in the heart is not working properly)
14. Increased risk of conduction system damage (the cardiac muscle cells in the wall of the heart that are sending out the signals to the heart muscle causing it to contract)
15. Perforation into the left ventricular chamber
16. Interaction of the Model 09108 lead with a coronary artery
17. Increased risk of loss of the MR Conditional labeling due to the lead abandonment
18. Extraction of the Model 09108 lead-related complications
19. Bio incompatibility, including toxicity, sensitivity and allergenic reactions from the ECG Belt material and Model 09108
20. Increased risk of infection due to lengthened procedure duration
21. Increased risk of infection due to additional access points
22. Increased risk of kidney damage due to additional contrast use
23. Increased risk of complications at the catheter insertion site
24. Stimulation of muscle other than heart muscle or stimulation of a nerve
25. Nerve damage (at incision/puncture points)
26. Inflammation or redness around the incision
27. In addition to the routine procedures patients will undergo, the x-ray exams used for this study could include possible increased CT scans of the heart, which minimally increases radiation doses.

Where is the study run from?
The sponsor of the study is Medtronic, Inc, located at 3200 Coral Sea St. NE, Mounds View, MN, USA. There are study sites in Australia, Brunei, Hong Kong, Malaysia, and Singapore.

When is the study starting and how long is it expected to run for?
Enrollment began in July 2019 and is expected to continue until October 2020.

Who is funding the study?
Medtronic, Inc.

Who is the main contact?
Katy A. Muckala, Sr. Clinical Research Specialist, Medtronic, Inc. (katy.a.muckala@medtronic.com).

Trial website

Contact information

Type

Public

Primary contact

Mrs Katy Muckala

ORCID ID

Contact details

3200 Coral Sea St. NE
Mounds View
55112
United States of America
2183482058
katy.a.muckala@medtronic.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Ventricle from Atrium Heart Failure

Acronym

VFAHF

Study hypothesis

The aim of the study is to characterize the acute cardiac resynchronization therapy (CRT) response of ventricle from atrium (VfA) pacing and traditional CRT using the standard deviation of activation times (SDAT) from the ECG belt technology

Ethics approval

1. Approved 10/07/2019, Institut Jantung Negara Research Ethics Committee (145, Jalan Tun Razak, Kuala Lumpur; 03 26178200), ref: IJNREC/411/2019.
2. Approved 09/09/2019, Bellberry Limited (123 Glen Osmond Road, Eastwood, South Australia, 5063; bellberry@bellberry.com.au; +61 8 8361 3222), ref: 2019-06-484.
3. Approved 09/07/2019, South Metropolitan Health Service Human Research Ethics Committee (Level 2, Education Building, Fiona Stanley Hospital, 14 Barry Marshall Parade, Murdoch, Western Australia, 6150), ref: RGS0000003291.

Approval pending at Hong Kong, Singapore and Brunei sites (anticipated by December 2019).

Study design

Prospective interventional non-randomized multicenter global investigational research feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Heart failure

Intervention

Subjects indicated for a CRT device will be recruited and implanted with a Model 09108 lead to test for CRT response. ECG Belt, EGM and 12 lead ECG will be collected during multiple pacing maneuvers. The Model 09108 lead will be removed, and the subject will receive their permanent CRT system.

Subjects will undergo assessments at baseline, implant, pre-hospital discharge and 1-month post-implant.

Intervention type

Device

Phase

Phase III

Drug names

Medtronic model 09108 lead

Primary outcome measure

1. Characterize the absence of complications related to either the Model 09108 lead implant procedure or the temporarily implanted Model 09108 lead through the first month of follow-up
2. Characterize the proportion of Model 09108 lead implants with ventricular pacing capture at baseline, implant, pre-hospital discharge and 1-month post-implant.

Secondary outcome measures

At baseline, implant, pre-hospital discharge and 1-month post-implant:
1. Characterize the acute CRT response of Ventricle from Atrium (VfA) pacing and traditional CRT using the standard deviation of activation times (SDAT) from the ECG belt technology
2. Characterize the implant success rate of the Model 09108 lead
3. Characterize the resynchronization success rate of the Model 09108 lead via the ECG belt
4. Characterize the voltage pacing capture thresholds, sensing and pacing impedance of the Model 09108 lead at implant
5. Characterize the implant procedure duration

Overall trial start date

15/07/2015

Overall trial end date

01/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Indicated for a CRT device system according to local guidelines
2. Implanted with a market-released Medtronic CRT device and a market-released Medtronic LV lead
3. Sign and date the study Informed Consent (IC) form
4. 18 years of age or older, or of legal age to give informed consent per local law

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Permanent/persistent AF or presenting with AF with ventricular rate ≥ 90 BPM
2. CIED or has another confounding device (e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator). Insertable cardiac monitors (ICMs) are acceptable.
3. Requires right-sided venous access or a right-sided device implant
4. Contraindication for standard transvenous cardiac pacing (e.g. mechanical right heart valve)
5. History of valve repair or replacement
6. Previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
7. Post heart transplant (subjects waiting for heart transplants are allowed in the study)
8. Unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
9. Currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
10. Congenital heart disease
11. Hypertrophic cardiomyopathy
12. History of chronic dialysis therapy
13. Less than 1-year life expectancy
14. Pregnant
15. Contraindicated for ≤ 1.0 mg of dexamethasone acetate
16. Subject meets any exclusion criteria required by local law
17. Weighs more than 300 lbs (136 kg)
18. Vulnerable adults

Recruitment start date

15/07/2019

Recruitment end date

01/10/2020

Locations

Countries of recruitment

Australia, Brunei, Hong Kong, Malaysia, Singapore

Trial participating centre

Institut Jantung Negara
Department of Cardiology Institut Jantung Negara Sdn Bhd 145 Jalan Tun Razak 50400 Kuala Lumpur
Selangor
50400
Malaysia

Trial participating centre

Prince of Wales Hospital
Department of Medicine and Therapeutics Prince of Wales Hospital Chinese University of Hong Kong 30-32 Ngan Shing Street
Shatin
000000
Hong Kong

Trial participating centre

Fiona Stanley Hospital
Department of Cardiology Fiona Stanley Hospital 11 Robin Warren Drive
Murdoch
6150
Australia

Trial participating centre

Warringal Private Hospital
216 Burgindy St.
Heidelberg
3084
Australia

Trial participating centre

National University Hospital
5 Lower Kent Ridge Road
Singapore
119074
Singapore

Trial participating centre

Gleneagles Jerudong Park Medical Centre
Jerudong Park
Bandar Seri Begawan
BG 3122
Brunei

Sponsor information

Organisation

Medtronic, Inc

Sponsor details

3200 Coral Sea St. NE
Mounds View
55112
United States of America
+1 2183482058
katy.a.muckala@medtronic.com

Sponsor type

Industry

Website

https://www.medtronic.com

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

No publication plans-early feasibility

IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available to anyone other than Medtronic and investigators in the study. This is a small, early feasibility study. There is not currently a publication plan for the study.

Intention to publish date

01/01/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/09/2019: Trial's existence confirmed by the Institut Jantung Negara Research Ethics Committee.