A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure

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.

Conditions

• Heart Failure

Interventions

PROCEDURE

Trans-ventricular-septal placement of LV pacing lead

OTHER

Pre-procedure speckle-tracking echocardiography

Assessment of site of latest mechanical activation

OTHER

Acute response assessment

Cardiac output monitoring

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Heart Research UK

  collaborator UNKNOWN

• Oxford University Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Tim Betts, MBChB · Oxford University Hospitals

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2016-09-30

Completion

2018-03-31

Countries

• United Kingdom

Study Locations