Trials / Unknown
UnknownNCT05829876
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- University Hospital Birmingham · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
Detailed description
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment. Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function. The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | High Frequency ECG Mapping | A high frequency ECG map will be performed to assess the optimum left ventricular pacing site. |
| OTHER | Q-LV Measurement | Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site. |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2023-04-26
- Last updated
- 2024-08-21
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05829876. Inclusion in this directory is not an endorsement.