A Randomized Sham-controlled Study of Pulmonary Vein Isol... | NCT04272762

Studies
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation

NCT04272762

Sponsor

East Sussex Hospitals NHS Trust

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Cryoablation
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2020Actual

Primary Completion Date

Mar 4, 2024Actual

Completion Date

Mar 4, 2024Actual

First Submitted Date

Feb 12, 2020

First Submission Date that Met QC Criteria

Feb 14, 2020

First Posted Date

Feb 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

Name	Class
Eastbourne Cardiology Research Charity Fund	UNKNOWN
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ablation	Active Comparator	pulmonary vein isolation	Procedure: Cryoablation
Placebo	Placebo Comparator	placebo procedure	Procedure: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cryoablation	Procedure	Pulmonary vein isolation with cryoablation	Ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation burden using continuous monitoring		6 months

Secondary Outcomes

Measure	Description	Time Frame
Time to symptomatic atrial tachyarrhythmia stratified by length of episode		6 months
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than or equal to 18 years
Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).
Referred for catheter ablation

Exclusion Criteria:

Long term persistent AF (continuous episode lasting more than 1)
Prior left atrium catheter or surgical atrial fibrillation ablation
Patients with other arrhythmias requiring ablative therapy
Left atrium (LA) ≥5.5 cm
Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
Awaiting cardiac surgery or PCI
Myocardial infarction within three months prior to enrolment.
Stroke or transient ischemic attack (TIA) within three months prior to enrolment
Unstable angina
Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
Any condition contraindicating chronic anticoagulation
Any untreated or uncontrolled hyperthyroidism or hypothyroidism
Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min)
Patients with metallic prosthetic valves
Pregnant or breastfeeding women
Medical conditions limiting expected survival to <1 year
History of claustrophobia or panic attacks
Left ventricular ejection fraction (LVEF) less than 35%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37309845	Background	Dulai R, Furniss SS, Sulke N, Freemantle N, Lambiase PD, Farwell D, Srinivasan NT, Tan S, Patel N, Graham A, Veasey RA. A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale. Clin Cardiol. 2023 Aug;46(8):973-980. doi: 10.1002/clc.24066. Epub 2023 Jun 13.
39221629

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative