Status:

RECRUITING

Ablate and Pace HIS Study

Lead Sponsor:

University Hospitals, Leicester

Collaborating Sponsors:

Medtronic

Conditions:

HIS Bundle Pacing

Atrial Fibrillation

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing. Despite the advances in AF ablation strategies, the outcome of ablation pr...

Detailed Description

The Ablate and Pace HIS Study is a single-centre, prospective randomised single-blinded study, recruiting a sub-population of patients with AF who are deemed not fit for rhythm control strategy. These...

Eligibility Criteria

Inclusion

  • Aged 18 or above
  • Symptomatic AF, New York Heart Association (NYHA) class II-IV
  • Willing to consent for the study
  • AF regardless type, deemed not suitable for rhythm control strategy that has been referred for AVN ablation with one of the following:
  • Impaired LV function, EF \<50 %. And or
  • Raised N-Terminal Pro B-type Natriuretic Peptide ( NT-ProBNP) \>365 ng/L

Exclusion

  • Patient who has already got a pacemaker in situ
  • Known severe LVSD when biventricular device is the thought to be the preferred pacing modality
  • Females in child bearing period
  • Lack of capacity to consent
  • Other serious medical condition with life expectancy of less than 1 year
  • Less than 18 years
  • Unwilling to consent for the study

Key Trial Info

Start Date :

October 24 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 29 2028

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06152406

Start Date

October 24 2023

End Date

February 29 2028

Last Update

January 5 2026

Active Locations (1)

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University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom, LE1 5WW

Ablate and Pace HIS Study | DecenTrialz