Trial Outcomes & Findings for An Assessment of Dual Site Left Ventricular Endocardial Pacing (NCT NCT02211456)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Mean of multiple recordings in each patient as detailed above

Results posted on

2021-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Having an ablation procedure with access to the left side of the heart Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max All patients underwent the pacing protocol
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Assessment of Dual Site Left Ventricular Endocardial Pacing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=15 Participants Having an ablation procedure with access to the left side of the heart Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
Age, Continuous	68 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United Kingdom	15 participants n=5 Participants
Ischaemic aetiology of left ventricular dysfunction	12 Participants n=5 Participants
Left ventricular ejection fraction	27 % STANDARD_DEVIATION 8 • n=5 Participants

PRIMARY outcome

Timeframe: Mean of multiple recordings in each patient as detailed above

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)

Outcome measures

Outcome measures
Measure	Participants n=15 Participants Having an ablation procedure with access to the left side of the heart Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
Acute Haemodynamic Response to Dual Left Ventricular Pacing	3.7 % difference Interval 1.0 to 6.3

Adverse Events

Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants n=15 participants at risk Having an ablation procedure with access to the left side of the heart Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol: Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
Nervous system disorders Stroke	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr James Gamble

Oxford University Hospitals NHS FT

Phone: 00441865221012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place