How does sinus node disease maintain atrial fibrillation?

Not Applicable

• Conditions: Sinus node disease; Circulatory System

• Registration Number: ISRCTN12363822
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 31 August 2020
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients undergoing first EP study and/or catheter ablation or undergoing pacemaker implantation for sinus node disease with no prior AF.
For the study groups:
1. Documented atrial fibrillation without sinus node disease
2. Documented atrial fibrillation with sinus node disease
3. SVT without AF and with normal sinus node function (control)
4. Sinus node disease without atrial fibrillation, requiring pacemaker implantation (control)
Sinus node disease will be defined as the presence of at least 2 of the following criteria: CSNRT > 550 ms in the absence of reversible causes, Post AF shock sinus recovery time >1200 ms in the absence of reversible causes, ECG evidence of sinus pause >3 seconds when awake in the absence of reversible causes, ECG evidence of sinus rates <45 bpm for more than 1 minute when awake in the absence of reversible causes, evidence of chronotropic incompetence on maximal exercise stress test (defined as reaching <80% of age predicted maximal heart rate at maximal exercise) in the absence of reversible causes (eg rate limiting medication and cardiac ischaemia). AF is defined as persistent atrial fibrillation in accordance with the European Society of Cardiology definition as AF that lasts for longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or DC cardioversion, after 7 days or more but has not been present continuously for 1 year or longer (long standing persistent AF).

All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.

Exclusion Criteria

1. Age < 18 or > 65
2. BMI > 35
3. Diabetes mellitus
4. Intubated/ventilated patients
5. Existing intravascular implanted cardiac device or prior device extraction
6. Prior cardiac surgery
7. Previous cardiac ablation for AF
8. Ischaemic heart disease
9. Uncontrolled type 2 or 3 hypertension
10. Structural heart disease
11. Infiltrative or inherited cardiomyopathy
12. Left ventricular systolic ejection fraction < 50%
13. Inability or unwillingness to discontinue antiarrhythmic medication
14. Pregnancy or participation in CTIMP

Post-procedure exclusion/withdrawal criteria:
1. Inability of the patient to tolerate a prolonged procedure due to discomfort, procedural difficulties leading to a significantly longer clinical procedure and therefore increased risk of complications

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The research is qualitative in nature. The primary outcome will be descriptive data characterising the role that SND plays in changing the electrical properties of the atrium that maintain atrial fibrillation, measured using cardiac electrogram at a single timepoint.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures