Surgery: Atrio-ventricular nodal ablation Surgery Atrio-ventricular nodal ablation
Conditions
Interventions
Our hypothesis is that better patient's exercise capacity and recovery of cardiac pumping function can be achieved by positioning the pacing leads at the site where blood flows out of the right lower
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: It has been estimated that a total of 80 patients will be required for this initial study (allowing for 7-15% drop outs, deaths etc). This was estimated using a two sided alpha of 0.05, and an 80% power to detect a 10% change in peak VO2 from a baseline of 20 ml/kg/min assuming a standard deviation of 4 ml/kg/min (20%). A total of 80 patients will be recruited and the investigator will be responsible for screening all patients listed for AV nodal ablation on clinical grounds. The patients selected for participation will be part of the investigators general patient population meeting the indications for the use of a permanent pacemaker system. The patients will be randomised and included in the study if they meet the inclusion criteria and give informed written consent. All patients who fulfill the eligibility criteria will be approached by the principal investigator. A patient information sheet will be provided. Only patients who provide written informed consent prior to the procedure will be included. A copy of the written consent will be stored in the medical records, the study file and a copy will be given to the patient. The investigator will sign in the case record form that informed written consent has been obtained and the date consent was obtained. Informed consent will involve individual discussion with the patient about the nature of the procedures in a language that is easy to comprehend. The potential risks and benefits will be explained to the patient and they will be given time to make a decision about participation. It will be made clear that there is a random allocation to the two groups (RVOT versus RVA selective site pacing) and the patient or the physician does not decide which group they are allocated. It will be made clear that the patient can withdraw at any time from the research and does not have to give an explanation and it will not affect their medical care in any way. It will be recommended that if possible the patient is given 24 hours to think about participation and discussing with family, friends or other healthcare professionals before signing the consent form.
Exclusion criteria
Exclusion criteria: 1. Indication for implantation of implantable cardioverter defribillator (ICD) because the heart is beating too fast or use of biventricular pacemaker 2. Evidence of left or right bundle branch block or QRS > 120 ms 3. Exercise limitation due to a pathological process e.g angina, respiratory, neurological or rheumatological disease 4. Significant valvular heart disease including indwelling prosthesis Current or recent participation in any other clinical investigation 5. Life expectancy less than 6 months 6. Patient inability to independently comprehend the patient information sheet or sign the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of functional capacity as measured by Peak VO2 (ml, kg, min) and exercise time (sec) (or 28-day), Peak Cardiac Output (l, min) and Peak Cardiac Power Output (watts) will be evaluated by categorical outcome measures using a Pearson's Chi-square test or Fisher's exact test as required. Continuous variables will be examined using a 2-sided unpaired t-test or a non-parametric equivalent. All tests will be evaluated at a significance level of 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed