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Clinical Trials/ISRCTN12363822
ISRCTN12363822
Active, not recruiting
未知

Endocardial mapping of atrial fibrillation in patients with sinus node disease

Manchester University NHS Foundation Trust0 sites40 target enrollmentJuly 19, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Sinus node disease
Sponsor
Manchester University NHS Foundation Trust
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 19, 2019
End Date
April 30, 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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