Isoprenaline infusion as a method of induction of atrial fibrillatio

Not Applicable

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Arrhythmia; Circulatory System

• Registration Number: ISRCTN17309312
• Lead Sponsor: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2015-12-31
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

All participants in all groups:
1. The participant must be willing to comply with the protocol requirements including travelling to the investigating hospital for the attendances required for the study
2. Provision of informed consent
3. Participants must be over 18 years of age

Group 1 – Paroxysmal Atrial Fibrillation Group
1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
2. Participants must have a pattern of symptoms and investigation results consistent with a diagnosis of paroxysmal atrial fibrillation

Group 2 – SVT Ablation Group
1. Participants must have a history of arrhythmia with documented regular, narrow complex tachycardia available on either 12 lead ECG or ambulatory ECG monitor recording
2. Participants must be listed to undergo an Electrophysiology study with a view to performing an ablation procedure
3. Participants must go on to have an ablation procedure for either AtrioVentricular Reentrant Tachycardia (AVRT) or AtrioVentricular Nodal Reentrant Tachycardia (AVNRT) with a defined procedural endpoint

Group 3 – Atrial Flutter Ablation Group
1. Participants must have a history of arrhythmia with 12 lead ECG documentation fulfilling prespecified criteria for diagnosis of common type (cavotricuspid isthmus dependent) atrial flutter
2. Participants must be listed to undergo a cavotricuspid isthmus ablation for common type atrial flutter
3. Participants must go on to have only a cavotricuspid isthmus ablation for common type atrial flutter
4. Sustained bidirectional cavotricuspid isthmus block must have been demonstrated as the endpoint for the ablation procedure

Group 4 – Pulmonary Vein Isolation Group
1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
2. Participants must be listed to undergo an ablation procedure for atrial fibrillation with the intent of the attending physician to perform pulmonary vein isolation alone as an ablation strategy
3. Participants must be in sinus rhythm at the time that they enter the Cardiac Electrophysiology Laboratory for their
ablation procedure.
4. Participants must have an ablation procedure for atrial fibrillation and this must have involved only ablation to achieve pulmonary vein isolation
5. Pulmonary vein isolation must have been demonstrated as the endpoint for the ablation procedure

Exclusion Criteria

All participants in all groups:
1. Allergy to Isoprenaline
2. Any treatment with Amiodarone in the 3 months prior to ablation procedure
3. Hypertrophic cardiomyopathy
4. Suspected acute myocarditis
5. Uncorrected, severe valvulopathy graded by transthoracic echocardiographic parameters
6. An Acute Coronary Syndrome within the last 6 months
7. Recent (within the last 6 months) or scheduled coronary revascularisation
8. Ongoing angina symptoms without investigations demonstrating the absence of myocardial ischaemia
9. Left ventricular ejection fraction measured at <30%
10. Symptoms of decompensated heart failure syndrome in the last 3 months
11. Severe obstructive lung disease
12. Pregnancy at the time of enrolment or a desire to become pregnant during the study period
13. Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
14. Unable to provide informed consent

Group 1 – Paroxysmal Atrial Fibrillation Group
15. Any past history of episode of persistent atrial fibrillation at the time of enrolment to the study
16. Treatment with any antiarrhythmic agent within six halflives
of that agent from before an administration of the study
drug infusion

Group 2 – SVT Ablation Group
1. Any past history of atrial fibrillation documented on 12 lead ECG or ambulatory ECG monitor
2. Any past history of atrial flutter documented on 12 lead ECG or ambulatory ECG monitor
3. Characterisation of SVT as any arrhythmia other than ANRT or AVNRT
4. Treatment with any antiarrhythmic agent within six halflives
of that agent from the ablation procedure (including intraprocedural
use) with the exception of isoprenaline and adenosine

Group 3 – Atrial Flutter Ablation Group
1. Characterisation of arrhythmia as any arrhythmia other than cavotricuspid
isthmus dependent atrial flutter at the time
of ablation
2. Treatment with any antiarrhythmic agent within six halflives
of that agent from the ablation procedure (including intraprocedural
use) with the exception of isoprenaline and adenosine

Group 4 – Pulmonary Vein Isolation Group
1. Requirement for a more extensive ablation strategy than pulmonary vein isolation alone
2. Intraprocedural treatment with any antiarrhythmic agent with the exception of isoprenaline and adenosine
3. Treatment with any antiarrhythmic agent in the days before the ablation within six halflives of that agent from the ablation procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified