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

NCT01818765 | Completed Results DMC

• 2 other identifiers: OUH-2013-20813/SC/0186
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac resynchronisation therapy; Endocardial; Pacing

Outcome Measures

Primary Outcomes (1)

• Number of Participants Free of Adverse Effects at 6 Months Post Procedure

  Acute: coronary arterial damage; tamponade or effusion; acute lead displacement; peri-procedural systemic thromboembolism; arrhythmia; bleeding Chronic: systemic thromboembolism; lead displacement, dysfunction or fracture; system infection; bleeding; arrhythmia; death

  6 months

Secondary Outcomes (7)

• Procedural Success - Number of Participants With Successful Delivery of Left Ventricular Lead Via Ventricular Transseptal Approach

  6 months

• NYHA Class

  Baseline, 6 months

• Number of Participants With >1 Point Improvement in EQ-5D-5L Quality of Life Score

  Baseline, 6 months

• Number of Participants With ≥10% Increase in 6-minute Walk Distance

  Baseline, 6 months

• Echocardiographic Response: Change in Ejection Fraction as Measured by Echocardiography From Baseline to 6 Months

  Baseline, 6 months

Study Arms (1)

Procedure

EXPERIMENTAL

Pre-procedure speckle-tracking echocardiography assessment of latest activation Trans-ventricular-septal placement of LV pacing lead Acute response assessment

Procedure: Trans-ventricular-septal placement of LV pacing lead; Other: Pre-procedure speckle-tracking echocardiography; Other: Acute response assessment

Interventions

Trans-ventricular-septal placement of LV pacing lead PROCEDURE

Procedure

Pre-procedure speckle-tracking echocardiography OTHER

Assessment of site of latest mechanical activation

Procedure

Acute response assessment OTHER

Cardiac output monitoring

Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Heart Research UK: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, OX3 7AT, United Kingdom

Location

Related Publications (8)

• Gamble JH, Bashir Y, Rajappan K, Betts TR. Left ventricular endocardial pacing via the interventricular septum for cardiac resynchronization therapy: first report. Heart Rhythm. 2013 Dec;10(12):1812-4. doi: 10.1016/j.hrthm.2013.07.033. Epub 2013 Jul 23. No abstract available.

  PMID: 23891954 BACKGROUND

• Bordachar P, Derval N, Ploux S, Garrigue S, Ritter P, Haissaguerre M, Jais P. Left ventricular endocardial stimulation for severe heart failure. J Am Coll Cardiol. 2010 Aug 31;56(10):747-53. doi: 10.1016/j.jacc.2010.04.038.

  PMID: 20797486 BACKGROUND

• Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.

  PMID: 22405632 BACKGROUND

• Khan FZ, Virdee MS, Gopalan D, Rudd J, Watson T, Fynn SP, Dutka DP. Characterization of the suitability of coronary venous anatomy for targeting left ventricular lead placement in patients undergoing cardiac resynchronization therapy. Europace. 2009 Nov;11(11):1491-5. doi: 10.1093/europace/eup292.

  PMID: 19880411 BACKGROUND

• Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014.

  PMID: 20797490 BACKGROUND

• Pratola C, Notarstefano P, Toselli T, Artale P, Squasi P, Baldo E, Ferrari R. Noncontact mapping of left ventricle during CRT implant. Pacing Clin Electrophysiol. 2010 Jan;33(1):74-84. doi: 10.1111/j.1540-8159.2009.02578.x. Epub 2009 Oct 10.

  PMID: 19821940 BACKGROUND

• Ginks MR, Shetty AK, Lambiase PD, Duckett SG, Bostock J, Peacock JL, Rhode KS, Bucknall C, Gill J, Taggart P, Leclercq C, Carr-White GS, Razavi R, Rinaldi CA. Benefits of endocardial and multisite pacing are dependent on the type of left ventricular electric activation pattern and presence of ischemic heart disease: insights from electroanatomic mapping. Circ Arrhythm Electrophysiol. 2012 Oct;5(5):889-97. doi: 10.1161/CIRCEP.111.967505. Epub 2012 Jul 25.

  PMID: 22832673 BACKGROUND

• Betts TR, Gamble JH, Khiani R, Bashir Y, Rajappan K. Development of a technique for left ventricular endocardial pacing via puncture of the interventricular septum. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):17-22. doi: 10.1161/CIRCEP.113.001110. Epub 2014 Jan 14.

  PMID: 24425419 BACKGROUND

Related Links

• UK NIHR Oxford Biomedical Research Centre

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr James Gamble
• Organization: Oxford university hospitals NHS Foundation Trust

drjgamble1@jhpg.net

+441865221012

Study Officials

• Tim Betts, MBChB

  Oxford University Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 26, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2018
• Last Updated: March 3, 2020
• Results First Posted: October 23, 2019

Record last verified: 2020-02

Locations

GB (1)