Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT02211456
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Assessment of Dual Site Left Ventricular Endocardial Pacing
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Dual Site Left Endocardial Pacing for Cardiac Resynchronisation Therapy
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOUBLE-CRT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: