N/A
N=20
A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01818765 ↗Enrolled (actual)
20
Serious AEs
16.7%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants Free of Adverse Effects at 6 Months Post Procedure — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trans-ventricular-septal placement of LV pacing lead (Procedure); Pre-procedure speckle-tracking echocardiography (Other); Acute response assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free of Adverse Effects at 6 Months Post Procedure |
15 | — |
| SECONDARY Procedural Success - Number of Participants With Successful Delivery of Left Ventricular Lead Via Ventricular Transseptal Approach |
20 | — |
| SECONDARY NYHA Class |
9 | — |
| SECONDARY Number of Participants With >1 Point Improvement in EQ-5D-5L Quality of Life Score |
9 | — |
| SECONDARY Number of Participants With ≥10% Increase in 6-minute Walk Distance |
10 | — |
| SECONDARY Echocardiographic Response: Change in Ejection Fraction as Measured by Echocardiography From Baseline to 6 Months |
41 | — |
| SECONDARY Biochemical Response: Change in BNP (B-type Natriuretic Peptide) Levels Between Baseline and Six Months |
95 | — |
| SECONDARY Clinical Outcomes |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants with standard indications for CRT AND
- Unable to position a LV lead via the standard coronary sinus route OR
- Non-responder to conventional CRT
Exclusion Criteria
- Patients in whom, in the opinion of the investigators, an alternative route for LV lead placement would be safer or more effective for the patient
- Contraindications to oral anticoagulation or inability to safely take oral anticoagulation.
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Participant who is terminally ill
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Data sourced from ClinicalTrials.gov (NCT01818765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.