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

NHS Trust

Status: Completed

Conditions: Atrial Fibrillation; Heart Failure; Ventricular Tachycardia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02211456

DOUBLE-CRT_72014

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Participants

Experimental group

Description:

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

Treatment:

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