Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

NCT01116557 | Terminated Phase 4 DMC

• 1 other identifier: BWI130
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

radiofrequency; ablation; atrial fibrillation; CARTO; THERMOCOOL; LASSO; PVAC

Outcome Measures

Primary Outcomes (3)

• Freedom from documented AF/AT recurrences without new AADs

  Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation.

  1 year follow-up post-ablation

• Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)

  at 6 months post-ablation

• Total procedure time

  at the time of the initial ablation procedure

Secondary Outcomes (19)

• Acute procedural success

  at the time of the initial ablation procedure

• Repeat ablation procedures for AF/AT recurrences

  through 3-12 month follow-up period post-ablation

• Freedom from documented AF/AT recurrences without AAD(s)

  through 3-12 month follow-up period post-ablation

• Freedom from documented AF/AT recurrences with AAD(s)

  through 3-12 month follow-up period post-ablation

• Freedom from documented AF/AT recurrences after more than one ablation procedure

  through 3-12 month follow-up period post-ablation

Study Arms (2)

THERMOCOOL® group

OTHER

Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.

Device: Radiofrequency Ablation procedure

PVAC® group

ACTIVE COMPARATOR

Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®

Device: Radiofrequency Ablation procedure

Interventions

Radiofrequency Ablation procedure DEVICE

Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.

Also known as: CARTO®3 System, LASSO® Circular Mapping Catheter, THERMOCOOL® Catheter

THERMOCOOL® group

Eligibility Criteria

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

You may qualify if:

• Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
• Failure of at least one AAD for PAF \[class I or III\] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all pre- and follow-up testing and requirements.

You may not qualify if:

• Longstanding persistent atrial fibrillation
• Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
• Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
• Previous ablation for AF
• LA size \> 55 mm
• LVEF \< 40% (ejection fraction)
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• CABG procedure within the last six (6) months
• Awaiting cardiac transplantation or other cardiac surgery
• Documented left atrial thrombus on imaging (eg, TEE)
• Diagnosed atrial myxoma
• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
• Acute illness or active systemic infection or sepsis
• Unstable angina
• Uncontrolled heart failure

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mattias Duytschaever, MD

  A.Z. St Jan AV

  PRINCIPAL INVESTIGATOR

• Yves De Greef, MD

  A.Z. Middelheim

  PRINCIPAL INVESTIGATOR

• Stuart Harris, MD

  Essex Cardiothoracic Centre

  PRINCIPAL INVESTIGATOR

• Peter Steen Hansen, MD

  Heart Center Varde

  PRINCIPAL INVESTIGATOR

• Pepijn Van Der Voort, MD

  Catharina Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Thomas Deneke, MD

  Krankenhaus Porz Cologne

  PRINCIPAL INVESTIGATOR

• Atul Verma, MD

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

• Arif Elvan, MD

  Isala

  PRINCIPAL INVESTIGATOR

• Yaariv Khaykin, MD

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 3, 2025

Record last verified: 2025-01