Subclavian Ansae Stimulation in AF (SAS-AF)

NCT05133414 | Completed

• 1 other identifier: 303347
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial Fibrillation (AF) is a common heart rhythm condition that affects over 3% of the total population. AF can lead to serious health problems such as heart failure or stroke and can also cause troublesome symptoms in some people. Although many advances have been made, there remains a pressing need to improvement treatment of AF. It is increasingly recognised that the brain and nerves can influence the electrical activity of the heart. Therefore, this research involves studying a new nerve target (Subclavian ansae) that is connected to the heart and can be a potential target for future treatment of AF. This nerve lies around an area close to an artery that runs to participant's left arm called left subclavian artery which can be approached via leg (key hole). The investigators aim to conduct this study in patients who have been referred for first time AF ablation.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Subclavian ansae stimulation

Outcome Measures

Primary Outcomes (5)

• Measuring the rate of change in heart rate (beats per minute) in response to subclavian ansae stimulation (SAS).

  Measuring the change in heart rate during and post stimulation of the SAS compared to baseline measurement at rest through the mapping catheter and surface ECG electrodes.

  During index procedure for catheter ablation

• Measuring the rate of change in blood pressure (mmHg) in response to subclavian ansae stimulation (SAS).

  Measuring the blood pressure (systolic and diastolic) through the arterial line during and post stimulation of the SAS compared to baseline measurements at rest.

  During index procedure for catheter ablation

• Measuring the rate of change in conduction velocity (m/s) within left and right atrium in response to subclavian ansae stimulation (SAS).

  Measuring the conduction velocity in each atrium and changes between the atrial conduction using the intra cardiac catheter electrodes post SAS stimulation comparing with baseline measurements at rest.

  During index procedure for catheter ablation

• Measuring the rate of change in action potential duration (ms) and effective refractive period (ms) in response to subclavian ansae stimulation (SAS).

  Measurements taken in both atria using the intra cardiac catheter electrodes post SAS stimulation compared to baseline measurements at rest.

  During index procedure for catheter ablation

• Proportion of participants where AF is inducible in response to Subclavian ansae stimulation

  Number of participants where AF is inducible in response to selective left subclavian ansae stimulation.

  During index procedure for catheter ablation

Secondary Outcomes (2)

• Determining the optimal output threshold (Volts/Kg) to selectively stimulate left subclavian ansae via the subclavian artery

  During index procedure for catheter ablation

• Safety and procedure specific complications

  During index procedure for catheter ablation

Study Arms (1)

Participants will receive stimulation of the left subclavian ansae.

EXPERIMENTAL

Participants as self-controlled cases for the study. Human cardiac haemodynamics and electrophysiological in response to left subclavian ansae stimulation will be studied.

Other: Selective left subclavian ansae stimulation

Interventions

Selective left subclavian ansae stimulation OTHER

Percutaneous, transarterial approach for target stimulation

Participants will receive stimulation of the left subclavian ansae.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent
• Age 18-80 years
• First time PAF ablation

You may not qualify if:

• Creatinine clearance (eGFR) \< 30mls/min
• Contraindication or unable to take anticoagulation
• Uncontrolled hypertension
• Contraindication for catheter ablation
• BMI \> 35
• Haemodynamically unstable
• Recent Stroke/ myocardial infarction
• Significant carotid artery stenosis
• Significant carotid artery stenosis or peripheral arterial disease
• Allergy to contrast
• Presence of pacemaker or implantable cardioverter defibrillator (ICD)

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malcolm Finlay

  Barts Heart Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: July 5, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)