Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation

NCT02344394 | Withdrawn

• 1 other identifier: 14-52
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to compare and assess the clinical outcomes of the standard of care hybrid ablation using epicardial ablation in conjunction with endocardial PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with additional RF ablation in a randomized, prospective population of patients with persistent AF of at least 6 months duration. All devices that are used are being utilized under the approved labeling of the devices.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation; Anti-Arrhythmia Agents; Catheter Ablation; surgical hybrid ablation

Outcome Measures

Primary Outcomes (1)

• Success or failure in patient with persistent AF to be free of 1) AF/Atrial tachycardia(AT)/Atrial flutter(AFL) and 2) class I and Ill antiarrhythmic drugs (AAD)

  The primary endpoint is success or failure in patients with persistent AF of at least 6 months duration to be AF/Atrial tachycardia (AT)/Atrial flutter (AFL) free and free of class I and III antiarrhythmic drugs (AAD) except for a previously failed or intolerant AAD in the same class following the 3 month blanking period through the 12 months post procedure follow-up visit. A failed AAD is defined as recurrence on that particular AAD. Crossover: After the three month blanking period, if the patient is in persistent AF, the patient may undergo DCCV and antiarrhythmic medication started. The follow up will start after this date.

  12 months

Secondary Outcomes (1)

• Success or failure in patient with persistent AF to achieve a >90% reduction in AF burden and freedom of class I and Ill antiarrhythmic drugs (AAD)

  12 months

Study Arms (2)

Hybrid Ablation-cryoballoon alone

OTHER

This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation consisting of pulmonary vein isolation with no further catheter ablation. This will be achieved using the nContact and Medtronic cryoballoon

Device: Medtronic Cryoballoon; Device: nContact

Hybrid ablation-cryoballoon plus RF

OTHER

This group receives the hybrid surgical ablation (epicardial-endocardial ablation) with epicardial ablation and endocardial ablation. Endocardial portion consists of pulmonary vein isolation using the cryoballoon with further catheter ablation, which may consist of ablation of complex fractionated electrograms and linear lesions. This will be achieved using the nContact and Medtronic Cryoballoon plus Thermocool Catheter.

Device: Medtronic Cryoballoon; Device: Thermocool Catheter; Device: nContact

Interventions

Medtronic Cryoballoon DEVICE

For endocardial pulmonary vein Isolation, an Arctic Front Advance Cardiac CryoAblation catheter (Medtronic, Mounds view, MN, USA) will be used.

Hybrid Ablation-cryoballoon alone; Hybrid ablation-cryoballoon plus RF

Thermocool Catheter DEVICE

For mapping and ablation from endocardium a 3.5 mm irrigated tip catheter (Navistar Thermocool SmartTouch Unidirectional Navigation Catheter, Biosense Webster, Diamond Bar, CA, USA) will be used.

Hybrid ablation-cryoballoon plus RF

nContact DEVICE

For Epicardial Ablation (the surgical portion of the Hybrid procedure), we will use the VisiTrax cardiac ablation device (nContact, Morrisville, NC, USA).

Hybrid Ablation-cryoballoon alone; Hybrid ablation-cryoballoon plus RF

Eligibility Criteria

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

You may qualify if:

• The subject is 18 years of age or older
• Left atrium \< 6.0 em (Trans Thoracic Echo - TTE- parasternal4 chamber view performed within 6 months)
• History of AF for at least 6 months
• Failed or refractory to one AAD (class I and/or Ill)
• Documentation of persistent AF
• Provided written informed consent
• Be eligible for the hybrid procedure

You may not qualify if:

• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one year life expectancy
• Previous cardiac surgery
• Previous abdominal surgery which will prevent epicardial access
• History of pericarditis
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices
• Patients with renal dysfunction who are not on dialysis (defined as GFR ::5 40)
• Patients who are contraindicated for anticoagulants such as heparin and coumadin
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias)
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Health Care, St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Jasbir S Sra, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 26, 2015
• Study Start: September 1, 2014
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: October 3, 2024

Record last verified: 2018-12

Locations

US (1)