Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

NCT01203748 | Completed DMC

• 1 other identifier: AF-09-102-ID-AB
• Study Type: interventional
• Target: 589
• Locations: 2 countries
• Sites: 2

Brief Summary

This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF

  Freedom from documented AF episodes \> 30 seconds at 18 months after one or two ablation procedure with/without antiarrhythmic medications (AAD). In the CT.gov website and in our protocol, we have stated the above primary endpoint (PE). This was the identical PE used in the original STAR AF I study. The intent of this PE was to present the success rates after both 1 procedure and after 2 procedures separately as was done in the original STAR AF I study. However, this is not entirely clear from the way the PE is stated. It may appear that our PE is the success rate after 2 procedures ("1 or 2" may imply "2"). Since our sample size calculation for the STAR AF II study was based on a single procedure success rate, the single procedure success rate with/without AAD will be used as the PE. The success rate after 2 procedures will be provided as the 1st. secondary endpoint. This clarification is done prior to locking the database and prior to any data analysis.

  18 months

Secondary Outcomes (18)

• Freedom from atrial arrhythmia

  18 months

• Freedom from atrial flutter and AT

  18 months

• Freedom from documented or not atrial arrhythmia

  18 months

• Freedom from symptomatic AF

  18 months

• Freedom from symptomatic atrial arrhythmia

  18 months

Study Arms (3)

PVI + Lines Ablation

EXPERIMENTAL

Procedure: PVI + Lines ablation

PVI Ablation

ACTIVE COMPARATOR

Procedure: PVI

PVI + CFE

EXPERIMENTAL

Procedure: PVI + CFE ablation

Interventions

PVI + Lines ablation PROCEDURE

Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

PVI + Lines Ablation

PVI PROCEDURE

Pulmonary vein antrum isolation

PVI Ablation

PVI + CFE ablation PROCEDURE

Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

PVI + CFE

Eligibility Criteria

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

You may qualify if:

• Patients age is18 years or greater;
• Patients undergoing a first-time ablation procedure for AF;
• Patients with persistent AF;
• Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
• At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
• Patients must be able and willing to provide written informed consent to participate in this investigation; and
• Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

You may not qualify if:

• Patients with paroxysmal AF;
• Patients with long-standing persistent AF;
• Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
• Patients with AF felt to be secondary to an obvious reversible cause;
• Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
• Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
• Patients who are pregnant.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

St. Andrews War Memorial Hospital

Brisbane, Queensland, Australia

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 8C3, Canada

Location

Related Publications (3)

• Terricabras M, Mantovan R, Jiang CY, Betts TR, Chen J, Deisenhofer I, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A; Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II) Investigators. Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2025473. doi: 10.1001/jamanetworkopen.2020.25473.

  PMID: 33275151 DERIVED

• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 DERIVED

• Verma A, Sanders P, Macle L, Deisenhofer I, Morillo CA, Chen J, Jiang CY, Ernst S, Mantovan R. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale. Am Heart J. 2012 Jul;164(1):1-6.e6. doi: 10.1016/j.ahj.2012.04.002.

  PMID: 22795275 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Atul Verma, Dr.

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CA (1); AU (1)