search
Back to results

An Assessment of Dual Site Left Ventricular Endocardial Pacing (DOUBLE-CRT)

Primary Purpose

Atrial Fibrillation, Ventricular Tachycardia, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation focused on measuring Endocardial pacing, Multi site pacing

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 1, 2014
Last Updated
February 11, 2021
Sponsor
Oxford University Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02211456
Brief Title
An Assessment of Dual Site Left Ventricular Endocardial Pacing
Acronym
DOUBLE-CRT
Official Title
Dual Site Left Endocardial Pacing for Cardiac Resynchronisation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ventricular Tachycardia, Heart Failure
Keywords
Endocardial pacing, Multi site pacing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Having an ablation procedure with access to the left side of the heart
Intervention Type
Procedure
Intervention Name(s)
Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol
Intervention Description
Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
Primary Outcome Measure Information:
Title
Acute Haemodynamic Response to Dual Left Ventricular Pacing
Description
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)
Time Frame
Mean of multiple recordings in each patient as detailed above

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim R Betts, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7AT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20797486
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.
Results Reference
background
PubMed Identifier
24525553
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.
Results Reference
background
PubMed Identifier
22312038
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.
Results Reference
background
PubMed Identifier
24425419
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.
Results Reference
background

Learn more about this trial

An Assessment of Dual Site Left Ventricular Endocardial Pacing

We'll reach out to this number within 24 hrs