An Assessment of Dual Site Left Ventricular Endocardial Pacing

NCT02211456 | Completed Results DMC

• 1 other identifier: DOUBLE-CRT_72014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling. Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. CRT requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. These two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function. The investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside. The investigators wish to assess whether:

1. 1.Using two wires within the left side of the heart gives a greater increase in heart function than one.
2. 2.It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat.
3. 3.Is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? They are investigating this in people with hearts that beat less effectively than normal.

Conditions

Atrial Fibrillation; Ventricular Tachycardia; Heart Failure

Keywords

Endocardial pacing; Multi site pacing

Outcome Measures

Primary Outcomes (1)

• Acute Haemodynamic Response to Dual Left Ventricular Pacing

  Acute haemodynamic response to pacing (change in Left Ventricular dP/dt max) between dual site Left Ventricular pacing and biventricular pacing Pacing protocols were performed with a baseline of 30 seconds of right ventricular pacing followed by two 30-second test configurations, and then a further baseline. The pacing configurations were tested, in a randomized order, 3 times each. Electrophysiology catheters were positioned at the right ventricular mid septum for baseline pacing, and at the left ventricular septum and at the left ventricular lateral wall, at the site of latest electrical activation i identified from a left ventricular electrical activation map This provided two single-site left ventricular pacing configurations, which could be combined to allow right ventricular and left ventricular lateral (Biventricular pacing) and left ventricular septal and left ventricular lateral (dual left ventricular pacing)

  Mean of multiple recordings in each patient as detailed above

Study Arms (1)

Participants

EXPERIMENTAL

Having an ablation procedure with access to the left side of the heart

Procedure: Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol

Interventions

Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol PROCEDURE

Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max

Participants

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 60 years or above.
• Having a suitable Atrial Fibrillation/flutter or Ventricular Tachycardia ablation procedure
• Evidence of abnormal Left Ventricular structure and function, as shown by Left Ventricular ejection fraction of less than 40%

You may not qualify if:

• Severe peripheral vascular disease (that would make arterial access more risky)
• Haemodynamic instability (such that a longer procedure is inadvisable)

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7AT, United Kingdom

Location

Related Publications (4)

• 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

• Shetty AK, Sohal M, Chen Z, Ginks MR, Bostock J, Amraoui S, Ryu K, Rosenberg SP, Niederer SA, Gill J, Carr-White G, Razavi R, Rinaldi CA. A comparison of left ventricular endocardial, multisite, and multipolar epicardial cardiac resynchronization: an acute haemodynamic and electroanatomical study. Europace. 2014 Jun;16(6):873-9. doi: 10.1093/europace/eut420. Epub 2014 Feb 12.

  PMID: 24525553 BACKGROUND

• Rogers DP, Lambiase PD, Lowe MD, Chow AW. A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure. Eur J Heart Fail. 2012 May;14(5):495-505. doi: 10.1093/eurjhf/hfs004. Epub 2012 Feb 6.

  PMID: 22312038 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

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Dr James Gamble
• Organization: Oxford University Hospitals NHS FT

james.gamble@ouh.nhs.uk

00441865221012

Study Officials

• Tim R Betts, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 7, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

GB (1)