Heart Failure Clinical Trial
Official title:
Tailor-CRT: Better Application of Cardiac Resynchronization Therapy by Automated and Improved Selection of Location and Timing of Stimulation
Verified date | September 2016 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. However, the best strategy to optimize lead positioning and device programming still remains to be established. Earlier work in our research group suggests that the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position.
Status | Completed |
Enrollment | 28 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Chronic heart failure with NYHA functional class II-IV - Left ventricular ejection fraction (LVEF) < 35% - Left bundle-branch block (LBBB) with QRS duration > 120 ms - In sinus rhythm Exclusion Criteria: - Atrial fibrillation - =4 premature ventricular complexes on standard 12-lead ECG - Age <18 years or > 80 years - Incapable of giving informed consent - Moderate to severe aortic valve stenosis |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Centre | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Medtronic, University Medical Center Groningen |
Netherlands,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between the increase in LV dP/dtmax and the D-VCG derived QRS area, obtained at different AV- and VV-intervals. | The optimal AV- and VV-interval produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the minimal QRS area derived from the D-VCG. The correlations will be expressed by the Pearson Correlation coefficient. | Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours | |
Primary | Correlation between the increase in LV dP/dtmax and the LVLED or VCG derived QRS area, obtained at different potential LV lead positions | The optimal LV lead position produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the longest LVLED or the minimal QRS area derived from the VCG. The correlations will be expressed by the Pearson Correlation coefficient. | Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours | |
Secondary | Correlations between QRS vector area, -angle and -amplitude derived from VCG and from D-VCG. | The correlations will be expressed by the Pearson Correlation coefficient. | Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours |
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