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Hybrid AbLaTion of Atrial Fibrillation (HALT-AF)

Primary Purpose

Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Arrhythmia

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

Endocardial Catheter Ablation

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥ 18 years
Persistent or Long-standing Persistent AF
Dilated left atrium
Suitable for either procedure

Exclusion Criteria:

Unable to provide written consent
Previous open-heart surgery
Active infection, oesophageal ulcer stricture or oesophageal varices
Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
Contraindication to anticoagulation, or active thrombus in left atrium despite therapeutic anticoagulation
Severe valvular heart disease
Unstable coronary artery disease
Uncontrolled ventricular arrhythmia
Heart attack or stroke within the last 90 days
Pregnant, breast-feeding, or women of childbearing age who plan to get pregnant within six months
Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures

Sites / Locations

St Georges University of LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Convergent Hybrid Ablation with Left Atrial Appendage Exclusion

Standard Endocardial Catheter Ablation

Arm Description

Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation

Standard endocardial catheter ablation

Outcomes

Primary Outcome Measures

Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications

Recurrence of persistent atrial arrhythmia during follow-up months).

Secondary Outcome Measures

Safety Endpoint

Safety endpoint of severe and non-severe complications as defined in the protocol

Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications

Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)

Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

To assess left ventricular structural remodelling and change in ventricular function in response to either procedure

Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)

To assess left atrial remodelling in response to either technique.

Left atrial size on Echocardiography

To evaluate the effects of the interventions on the patient's symptoms and quality of life.

Change in European Heart Rhythm Association (EHRA) AF Symptom score

To evaluate the effects of the interventions on the patient's symptoms and quality of life.

Change in New York Heart Association (NYHA) class

To evaluate the effects of the interventions on the patient's quality of life.

Change in EuroQol Quality of life Score (EQ5D)

To evaluate the effects of the interventions on the patient's quality of life.

Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)

To evaluate Quality Adjusted Life Years (QALYs) accrued during the trial period.

Analysis from Quality of Life scores

Full Information

NCT ID

NCT05411614

First Posted

May 20, 2022

Last Updated

June 6, 2022

Sponsor

St. George's Hospital, London

1. Study Identification

Unique Protocol Identification Number

NCT05411614

Brief Title

Hybrid AbLaTion of Atrial Fibrillation

Acronym

HALT-AF

Official Title

A Randomised Controlled Trial Comparing Hybrid Convergent Ablation to Standard Catheter Ablation in Patients With Non-Paroxysmal Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. George's Hospital, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF)

Detailed Description

The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF. Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Arrhythmia, Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Convergent Hybrid Ablation with Left Atrial Appendage Exclusion

Arm Type

Experimental

Arm Description

Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation

Arm Title

Standard Endocardial Catheter Ablation

Arm Type

Active Comparator

Arm Description

Standard endocardial catheter ablation

Intervention Type

Device

Intervention Name(s)

AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

Other Intervention Name(s)

Convergent Hybrid Epicardial Endocardial Ablation Procedure with concomitant left atrial appendage exclusion

Intervention Description

Minimally-invasive epicardial ablation with left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation

Intervention Type

Device

Intervention Name(s)

Endocardial Catheter Ablation

Other Intervention Name(s)

Percutaneous Catheter Ablation

Intervention Description

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Primary Outcome Measure Information:

Title

Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications

Description

Recurrence of persistent atrial arrhythmia during follow-up months).

Time Frame

Measured from the end of a 3-month blanking period up to 24 months

Secondary Outcome Measure Information:

Title

Safety Endpoint

Description

Safety endpoint of severe and non-severe complications as defined in the protocol

Time Frame

Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure

Title

Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications

Description

Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

Time Frame

Measured from the end of a 3- month blanking period up to 24 months

Title

Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)

Description

Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

Time Frame

Measured from the end of a 3- month blanking period up to 24 months

Title

To assess left ventricular structural remodelling and change in ventricular function in response to either procedure

Description

Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)

Time Frame