Pacing the ventricle from the atrium in heart failure patients

ISRCTN	ISRCTN47824547
DOI	https://doi.org/10.1186/ISRCTN47824547

Submission date: 29/08/2019
Registration date: 18/09/2019
Last edited: 30/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
July 2015 to February 2023

Who is funding the study?
Medtronic, Inc. (USA)

Who is the main contact?
Joy A. Aso, Clinical Research Specialist, Medtronic, Inc. (joy.a.aso@medtronic.com)

Contact information

Ms Joy Aso
Public

3200 Coral Sea St. NE
Mounds View
55112
United States of America

Phone	+1 6124138690
Email	joy.a.aso@medtronic.com

Study information

Study design	Prospective interventional non-randomized multicenter global investigational research feasibility study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	No participant information sheet available
Scientific title	Ventricle from Atrium Heart Failure
Study acronym	VFAHF
Study objectives	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(s)	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. 4. Approved 14/02/2020 National Healthcare Group Domain Specific Review Board (Nexus@One-North (South Tower) 3 Fusionopolis Link 03-08, Singapore, Singapore), ref: 2019/00790 5. Approved 29/10/2019. Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (8/F Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK), ref: 2019.452-T
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	15/07/2015
Completion date	20/02/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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. Able to 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 5. Subject is willing and able to comply with the study protocol
Key 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
Date of first enrolment	15/07/2019
Date of final enrolment	11/01/2023

Locations

Countries of recruitment

Australia
Brunei Darussalam
Hong Kong
Malaysia
Singapore

Study participating centres

Institut Jantung Negara

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

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

Fiona Stanley Hospital

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

Warringal Private Hospital

216 Burgindy St.
Heidelberg
3084
Australia

National University Hospital

5 Lower Kent Ridge Road
Singapore
119074
Singapore

Sponsor information

Medtronic, Inc
Industry

3200 Coral Sea St. NE
Mounds View
55112
United States of America

Phone	+1 2183482058
Email	katy.a.muckala@medtronic.com
Website	https://www.medtronic.com
"ROR"	https://ror.org/00grd1h17

Funders

Funder type

Industry

Medtronic
Private sector organisation / For-profit companies (industry)

Alternative name(s): Medtronic Inc.
Location: United States of America

Results and Publications

Intention to publish date	01/01/2024
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	No publication plans - early feasibility
IPD sharing plan	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.

Editorial Notes

30/01/2023: A contact was updated.
26/01/2023: A contact was updated.
08/09/2022: The following changes were made to the trial record:
1. Ethics approval details added.
2. The Phase was changed from Phase III to Not Applicable.
3. The inclusion criteria were updated.
4. The recruitment end date was changed from 30/04/2021 to 11/01/2023.
5. The overall trial end date was changed from 01/08/2021 to 20/02/2023.
6. The intention to publish date was changed from 01/01/2022 to 01/01/2024.
7. Gleneagles Jerudong Park Medical Centre was removed as a trial participating centre.
15/05/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2020 to 30/04/2021.
2. The overall trial end date was changed from 01/01/2021 to 01/08/2021.
3. Contact details updated.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
17/09/2019: Trial's existence confirmed by the Institut Jantung Negara Research Ethics Committee.