Investigation of Therapeutic Ablation Versus Cardioversion for AF

NCT03907982 | Completed Results DMC

• 1 other identifier: ORBITA-AF Pilot study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.

Conditions

Persistent Atrial Fibrillation; Cardiac Arrhythmia

Keywords

Cardiac ablation; Cardioversion; pacemaker; implantable cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

• Recurrence of Persistent AF (of AF Episode Lasting > 7 Days).

  Data on epsiodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system

  Within 12 months following the procedure

Secondary Outcomes (8)

• Death

  Within 12 months of study recruitment

• Rates of Subject Hospital Re-admission

  Within 12 months following the procedure

• Procedural Complications

  At the time of the procedure

• Bleeding Events

  Within 7 days of the procedure

• Rates of Repeat Procedures

  within 12 months following the procedure

Study Arms (2)

DCCV + PVI

EXPERIMENTAL

DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation) At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.

Procedure: DC Cardioversion; Procedure: Pulmonary vein isolation; Device: Implantable loop recorder

DC cardioversion (DCCV)

ACTIVE COMPARATOR

Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.

Procedure: DC Cardioversion; Device: Implantable loop recorder

Interventions

DC Cardioversion PROCEDURE

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); DCCV + PVI

Pulmonary vein isolation PROCEDURE

The cryoballoon (CE marked) 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 freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.

DCCV + PVI

Implantable loop recorder DEVICE

The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.

Also known as: LINQ

DC cardioversion (DCCV); DCCV + PVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent
• Age 18-80 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
• Known contraindication to or unable to tolerate amiodarone
• Uncontrolled hypertension
• Contraindication to catheter ablation
• BMI \> 35

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Medtronic: collaborator

Study Sites (1)

Barts Health NHS Trust - St Bartholomew's Hospital and Whipps Cross Hospital

London, EC1 6BQ, United Kingdom

Location

Related Publications (6)

• 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: 24850821 BACKGROUND

• 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: 25184861 BACKGROUND

• 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: 15574854 BACKGROUND

• 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: 24948694 BACKGROUND

• 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: 23239742 BACKGROUND

• 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: 29103656 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Malcolm Finlay, Principal Investigator
• Organization: Barts and London NHS trust

malcolm.finlay1@nhs.net

+442037658635

Study Officials

• Richard Schilling, FRCP MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Internal Pilot as part of a future study, Randomised, blinded, controlled trial with 2 arms.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: April 9, 2019
• Study Start: October 1, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Locations

GB (1)