Applications of body surface mapping in cardiac resynchronisation therapy and ventricular tachycardia

ISRCTN ISRCTN35782567
DOI https://doi.org/10.1186/ISRCTN35782567
Secondary identifying numbers RGHT000233
Submission date
03/05/2007
Registration date
30/07/2007
Last edited
02/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jennifer Adgey
Scientific

Regional Medical Cardiology Centre
1st Floor West Wing
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

Study information

Study designNon randomised controlled trial.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study objectives1. Electrocardiographic Imaging (ECGI) using potentials derived from the body surface can be used to identify electrical dyssynchrony within the Left Ventricle (LV), along with activation patterns and regions of slow conduction. It could therefore be used to predict response to cardiac resynchronisation therapy, and ultimately to guide placement of the LV pacing lead to the optimal site.
2. ECGI using body surface potentials acquired noninvasively is of comparable accuracy to endocardial data acquired invasively in determining sites of pacing of the LV endocardium and patterns of activation.
3. ECGI is comparable to endocardial data acquired invasively in locating the origin of Ventricular Tachycardia (VT) substrates and may provide useful information over and above endocardial data to aid radiofrequency ablation of this tachyarrhythmia.
Ethics approval(s)The Office for Research Ethics Committees in Northern Ireland (ORECNI), approved on 16/09/2005 (ref: 05/NIR01/139)
Health condition(s) or problem(s) studiedLeft ventricular dysfunction
Intervention1. CRT study
This is a pilot study during which 50 consecutive patients undergoing CRT implantation will be identified and worked up appropriately (there is no control group in this study and all participants will be given the same intervenions). All participants will undergo baseline assessment to include echocardiography, 6 minute walk testing, cardiopulmonary stress testing, quality of life assessment (questionnaire) and N-terminal Pro-BNP measurement. Body Surface Mapping (BSM) will be performed at baseline and the day following device implantation during different pacing modalities. They will then be followed up with a single visit at 6 months, at which time all of these tests will be repeated.

2. ECGI validation study:
A qualitative study comparing ECGI with data acquired invasively using noncontact endocardial mapping as gold standard. 10 patients undergoing invasive ElectroPhysiological Studies (EPS) requiring access to the left ventricle will be recruited. All patients will have an ECHO at baseline and undergo simultaneous body surface mapping and invasive endocardial mapping during muti-site pacing of the LV endocardium. BSM utilises a plastic 80-electrode mapping harness applied to the anterior and posterior torso. Noncontact endocardial mapping uses the previously validated EnSite 3000 system. This study will enable a qualitative comparison of both imaging modalities for localisation of pacing sites as well as activation sequences. There will be no follow-up for the patients in this sub-study.

3. VT study:
10 patients requiring VT ablation or simply EPS for induction of ventricular arrhythmias will be studied using both invasive and noninvasive modalities. This is a purely qualitative study.
Intervention typeOther
Primary outcome measureCRT study:
Response to CRT (assessed clinically using echo, 6 minute walk distance, cardiopulmonary stress testing, and functionally using quality of life questionnaire and NYHA symptom class). This can be assessed in conjunction with pacing site localisation using ECGI in relation to regions of slow conduction/scar tissue.

ECGI validation and VT studies: These are qualitative studies whereby ECGI data and data acquired invasively are compared directly. Therefore there is no discrete end-point.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2005
Completion date31/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants70 (CRT study, 50; ECGI validation study, 10; VT study, 10)
Key inclusion criteriaCardiac Resynchronization Therapy (CRT) study:
1. Poor LV function with ejection fraction on echocardiogram (ECHO) <35%
2. Symptomatic with New York Heart Association (NYHA) class 2-4
3. Dilated LV (>55 mm)
4. Any QRS duration (representing the duration of ventricular depolarisation)
LV dysfunction can be of any aetiology. All patients must be able and willing to give writted informed consent.

ECGI validation study:
Patients must require EPS/ablation of tachyarrhythmias requiring LV access e.g. VT ablation/EPS, Brugada EPS, left sided pathways. All must be willing and able to give written informed consent.

VT study:
All patients must require EPS for induction of LV tachyarrhythmias or ablation of VT. Again all must give written informed consent.
Key exclusion criteriaCRT study:
1. Ejection fraction on ECHO >35%
2. Unable or unwilling to come back for 6 month follow-up
3. Unable or unwilling to give written informed consent

ECGI validation and VT studies:
1. Procedures not requiring access to the LV
2. Bleeding conditions
3. Clotting disorders
4. Unwilling to give written informed consent
5. Age <18 years
Date of first enrolment01/10/2005
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Regional Medical Cardiology Centre
Belfast
BT12 6BA
United Kingdom

Sponsor information

Royal Victoria Hospital (UK)
Hospital/treatment centre

c/o Professor Ian Young
Royal Research Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

ROR logo "ROR" https://ror.org/03rq50d77

Funders

Funder type

Not defined

Frances and Augustus Newman Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2007 Yes No