CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Trans-ventricular-septal placement of LV pacing lead +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01818765
NCT01818765N/ACompleted

Left Ventricular Endocardial Pacing Through the Ventricular Septum

Oxford University Hospitals NHS Trust·interventional·Posted Mar 26, 2013·Updated Mar 3, 2020

In Brief

A clinical study evaluating Trans-ventricular-septal placement of LV pacing lead, Pre-procedure speckle-tracking echocardiography, and 1 other intervention for Heart Failure. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the symptoms of selected patients with heart failure, and to reduce hospital admission and death rates in these patients. CRT can improve cardiac function by improving the coordination of the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of the veins running around the outside of the heart, to stimulate the outside of the left ventricle (main pumping chamber). There are two particular issues with this standard technique. In some patients it is not possible to get the wire into the coronary sinus due to difficult vein shapes, and in others the wire can be put there, but it does not end up in a suitable position to act on the heart enough to improve heart function. This is thought to be a major part of the reasons why one in four patients does not improve with CRT ("non-responders"). The investigators have developed a novel method of pacing the left ventricle of the heart by putting the wire through a tiny hole made in the muscle between the left and right ventricles and pacing the inside surface of the left ventricular chamber. This will allow patients in whom the coronary sinus cannot be used to have CRT. The investigators will also offer it to patients who have not improved with CRT, as there is evidence that they may respond to this procedure due to physiological benefits from pacing the inside rather than the outside and also the ability to steer the lead anywhere on the inner surface. The investigators have performed this new procedure in a small number of patients already. This study will allow closer follow-up of more patients, and also investigation of ways to optimize results of the procedure for these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2016
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.3 years ago

Interventions

Trans-ventricular-septal placement of LV pacing leadprocedure

Pre-procedure speckle-tracking echocardiographyother

Assessment of site of latest mechanical activation

Acute response assessmentother

Cardiac output monitoring