NCT06096246

Brief Summary

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with catheter ablation for persistent atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jul 2024

Longer than P75 for not_applicable

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 Progress53%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

September 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

July 26, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2027

Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 21, 2023

Last Update Submit

September 1, 2025

Conditions

Persistent Atrial FibrillationCardiac ArrhythmiaCatheter Ablation

Outcome Measures

Primary Outcomes (2)

  • Recurrence of Persistent AF (AF episode lasting > 7 days) or left atrial ablation/ DC Cardioversion for atrial arrhythmia after 6 weeks of blanking period.

    Rates of recurrence of arrhythmia and data on episodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system \[ rhythm on ILR ECG\]

    Within 12 months following the procedure

  • A change in the burden of AF, as measured by continuous monitoring through ILR (Implantable loop recorder) at 3 months

    Percentage time the patient is in AF as measured by the ILR device (in percentage) compared to pre-randomisation

    3 months post randomisation

Secondary Outcomes (15)

  • Death

    Within 12 months of study index procedure.

  • Rates of Subject Hospital re-admission

    Within 12 months of study index procedure.

  • Procedural complications

    Up to 7 days post procedure

  • Bleeding events

    Within 7 days of the index procedure

  • Rates of Repeat procedures

    within 12 months following the procedure

  • +10 more secondary outcomes

Study Arms (2)

Experimental: DCCV + PVI

ACTIVE COMPARATOR

An implantable loop recorder will be inserted in the pre pectoral area with local anaesthetic at least one week before the randomisation. Two femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for ablation and for phrenic nerve pacing during the procedure. DC cardioversion (DCCV) plus Pulmonary Vein Isolation - At the end of pulmonary vein isolation, DCCV is performed (if the patient is still in AF).

Procedure: Pulmonary vein isolationProcedure: DC CardioversionDevice: Implantable loop recorderProcedure: Femoral sheath insertion

DC cardioversion (DCCV) + Sham procedure

SHAM COMPARATOR

An implantable loop recorder will be inserted in the pre-pectoral area with local anaesthetic at least one week before the randomisation. Two femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for intermittent phrenic nerve pacing during the procedure. DC Cardioversion and Sham procedure will be performed after randomisation. Intermittent phrenic nerve pacing will be employed for the sham group through the femoral venous sheath using a quadripolar catheter.

Procedure: DC CardioversionDevice: Implantable loop recorderProcedure: Femoral sheath insertion

Interventions

Pulmonary vein isolationPROCEDURE

The catheter ablation (with a CE \[Conformité Européenne\] marked device) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential ablation around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.

Also known as: Catheter ablation
Experimental: DCCV + PVI
DC CardioversionPROCEDURE

DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.

DC cardioversion (DCCV) + Sham procedureExperimental: DCCV + PVI
Implantable loop recorderDEVICE

The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at least a week before the randomisation. The device will provide a continuous recording of the heart rhythm and rate, and will be able to download duration of AF episodes via a home monitoring system to establish the primary endpoint of the study .

Also known as: Reveal LINQ
DC cardioversion (DCCV) + Sham procedureExperimental: DCCV + PVI
Femoral sheath insertionPROCEDURE

Two femoral sheaths (7Fr) will be inserted using ultrasound guidance under local anaesthetic.

DC cardioversion (DCCV) + Sham procedureExperimental: DCCV + PVI

Eligibility Criteria

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

You may qualify if:

  • Ability to give informed consent
  • Age 18-85 years
  • Persistent AF (atrial fibrillation lasting \> 7days) of total continuous duration \<2 years as documented in medical notes.
  • Patients being considered for cardioversion.

You may not qualify if:

  • Creatinine clearance (eGFR) \< 30mls/min
  • Contraindication or unable to take anticoagulation
  • Uncontrolled hypertension
  • Contraindication for catheter ablation
  • BMI \> 40
  • Patients in Persistent AF who have had more than one previous cardioversion.
  • Established diagnosis of Hypertrophic cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

RECRUITING

Related Publications (7)

  • Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, Brindley D, Savulescu J, Beard DJ, Carr AJ. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014 May 21;348:g3253. doi: 10.1136/bmj.g3253.

    PMID: 24850821RESULT

  • Redberg RF. Sham controls in medical device trials. N Engl J Med. 2014 Sep 4;371(10):892-3. doi: 10.1056/NEJMp1406388. No abstract available.

    PMID: 25184861RESULT

  • Miller FG, Kaptchuk TJ. Sham procedures and the ethics of clinical trials. J R Soc Med. 2004 Dec;97(12):576-8. doi: 10.1177/014107680409701205. No abstract available.

    PMID: 15574854RESULT

  • Jones C, Pollit V, Fitzmaurice D, Cowan C; Guideline Development Group. The management of atrial fibrillation: summary of updated NICE guidance. BMJ. 2014 Jun 19;348:g3655. doi: 10.1136/bmj.g3655. No abstract available.

    PMID: 24948694RESULT

  • Brim RL, Miller FG. The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent. J Med Ethics. 2013 Nov;39(11):703-7. doi: 10.1136/medethics-2012-101045. Epub 2012 Dec 13.

    PMID: 23239742RESULT

  • Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2.

    PMID: 29103656RESULT

  • Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.

    PMID: 15020033RESULT

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Richard Schilling, FRCP MD

    Barts & The London NHS Trust

    STUDY CHAIR

  • Malcolm Finlay

    Barts & The London NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malcolm Finlay, FRCP PhD

CONTACT

02037658635malcolm.finlay1@nhs.net

Vijayabharathy Kanthasamy, MRCP

CONTACT

02037658635vijayabharathy.kanthasamy@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patient and physician - blinded randomisation to intervention (DCCV, or Pulmonary Vein Isolation plus DCCV) Once subject participation in the trial is complete, the patient and physician will be unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised, blinded, controlled trial with 2 arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 23, 2023

Study Start

July 26, 2024

Primary Completion (Estimated)

July 26, 2027

Study Completion (Estimated)

December 5, 2027

Last Updated

September 3, 2025

Record last verified: 2025-09

Locations

GB(1)