Assessing the Capability of Cardiogoniometry (CGM) to Detect Changes in Cardiac Resynchronisation Therapy Device Settings

NCT02803879 | Completed

• 1 other identifier: 15/NW/0479
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients with heart failure require treatment called cardiac-resynchronisation therapy (CRT) which involves putting a pacemaker into the heart to make both ventricles (the lower chambers of the heart) contract together, making the pumping of the blood to the rest of the body more efficient. it is important to get the CRT pacemaker checked to make sure that it is working correctly and performing its job. However, it can be difficult to adjust the settings of the pacemaker just the right amount to ensure the heart is pumping efficiently. One of the ways this can be done is by using a special machine which uses ultrasound to make a 2-dimensional image of the heart called an echocardiogram. This technique can also be used to measure the flow of blood in the heart and calculate how efficient it is at pumping blood. However adjusting the settings of the pacemaker with this device is difficult to use and time consuming. Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently. Furthermore, recent research has shown that this is better than echocardiogram at optimising pacemaker device settings. A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a 3-dimensional view of the hearts electrical activity and has already been shown to be better than normal ECG at diagnosing certain conditions like angina and heart attacks. However it has never been used to try optimise the settings of the pacemakers used in CRT and may be quicker and easier to use than then other methods available. More importantly it is hoped by doing this it will reduce the symptoms that patients suffer as it is making the heart pump more efficiently. As it has been untested and never used in this setting before, and there it is necessary to find out if the CGM machine will recognise when the settings on the pacemaker are changed. The aims of this study is to see if the CGM machine can pick up changes to pacemaker settings, with the hope of running a later study to see if it can be used to optimise settings on the pacemaker used in CRT.

Conditions

Heart Failure

Keywords

cardiac resynchronisation therapy; cardiogoniometry

Outcome Measures

Primary Outcomes (4)

• Mean cardiac axis with no pacing

  Mean cardiac axis of participants when they are not being paced will be calculated with 95% confidence intervals.

  Within the first 30 days after end of participant enrollment

• Mean cardiac axis with rv pacing

  Mean cardiac axis of participants when they are being paced from the RV will be calculated with 95% confidence intervals.

  Within the first 30 days after end of participant enrollment

• Mean cardiac axis with lv pacing

  Mean cardiac axis of participants when they are being paced from the LV will be calculated with 95% confidence intervals.

  Within the first 30 days after end of participant enrollment

• Mean cardiac axis with biv pacing

  Mean cardiac axis of participants when they are being biventricular paced will be calculated with 95% confidence intervals.

  Within the first 30 days after end of participant enrollment

Study Arms (1)

Cardiogoniometry (CGM)

EXPERIMENTAL

All patients attending clinic for follow up appointments following the implantation of a CRT device will be eligible for inclusion in the study. If they consent for enrolment in the study each patient will undergo a series of 4 CGM recordings whilst in their follow up appointment. They will undergo each of these during different pacemaker settings. These are: 1) No pacing, 2) Paced from the right ventricular lead; 3) Paced from the left ventricular lead and 4) Paced from both ventricular leads. After this has been done the participants involvement in the study will have finished.

Device: Cardiogoniometry

Interventions

Cardiogoniometry DEVICE

Cardiogoniometry (CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending follow up clinic with a CRT device implanted.
• Patients have to be receiving CRT therapy - in other words, the device has to be functioning correctly.
• Aged 18 or over.
• The patient has been informed of the nature of the study and has provided full written informed consent.

You may not qualify if:

• Patients unable to give informed consent including those with communication difficulties due to poor English.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (1)

• Brown OI, Nikolaidou T, Beddoes G, Hoye A, Clark AL. The HF-CGM Study: An Analysis of Cardiogoniometric Axes in Patients With Cardiac Resynchronization Therapy. IEEE Trans Biomed Eng. 2018 Aug;65(8):1711-1716. doi: 10.1109/TBME.2017.2769060. Epub 2017 Nov 2.

  PMID: 29989935 BACKGROUND

Related Links

• Abstract Link

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: June 17, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

GB (1)