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Investigation of Therapeutic Ablation Versus Cardioversion for AF

NCT03907982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-26

Study results available
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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

Interventions

PROCEDURE

DC Cardioversion

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.

PROCEDURE

Pulmonary vein isolation

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.

DEVICE

Implantable loop recorder

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Richard Schilling, FRCP MD · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-04-26
Completion
2023-04-26

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907982 on ClinicalTrials.gov