Clinical trial NCT02211456: An Assessment of Dual Site Left Ventricular Endocardial Pacing
Official title: Dual Site Left Endocardial Pacing for Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Ventricular Tachycardia
Heart Failure
Keywords: Endocardial pacing
Multi site pacing
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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. Using two wires within the left side of the heart gives a greater increase in heart function than one.
2. It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat.
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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

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

Primary outcomes:
measure: Acute Haemodynamic Response to Dual Left Ventricular Pacing
timeFrame: Mean of multiple recordings in each patient as detailed above
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Tim R Betts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.