NCT04664686

Brief Summary

70 patients with heart failure, AF and CRT with BiV\<95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
17mo left

Started Oct 2021

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2021Sep 2027

First Submitted

Initial submission to the registry

December 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

December 10, 2020

Last Update Submit

January 23, 2026

Conditions

Atrial FibrillationHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Difference in ejection fraction

    On 2D echocardiography

    6 months

Secondary Outcomes (8)

  • Difference in left ventricular end systolic volume

    6 months

  • Difference in biventricular pacing percentage

    6 months

  • Difference in quality of life

    6 months

  • Difference in NYHA class

    6 months

  • Difference in heart failure symptoms

    6 months

  • +3 more secondary outcomes

Study Arms (2)

AF catheter ablation

ACTIVE COMPARATOR
Procedure: AF catheter ablation

AV node ablation

ACTIVE COMPARATOR
Procedure: AV node ablation

Interventions

AV node ablationPROCEDURE

AV node ablation

AV node ablation
AF catheter ablationPROCEDURE

Isolation of all four pulmonary veins and additional lesions, considered indicated by the operator

AF catheter ablation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
  • QRS duration \>120ms on surface ECG, severe left ventricular systolic impairment (EF≤35%) and clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV) at time of CRT implant or upgrade
  • Successful CRT implant or upgrade including atrial lead
  • Biventricular pacing percentage \<95% secondary to atrial fibrillation at least 3 months post implant or upgrade
  • Clinically indicated for AV node ablation

You may not qualify if:

  • Life expectancy \<1 year
  • Presence of atrial or ventricular thrombus
  • Permanent atrial fibrillation
  • Mechanical aortic valve replacement
  • Severe peripheral vascular disease
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  • Participation in other studies with active treatment / investigational arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher A Rinaldi

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher A Rinaldi

CONTACT

02071889257aldo.rinaldi@kcl.ac.uk

Felicity de Vere

CONTACT

02071889257felicity.de_vere@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 11, 2020

Study Start

October 19, 2021

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

GB(1)