Cryoballoon Targeting Atrial Fibrosis in Atrial Fibrillation

NCT03489096 | Withdrawn FDA Device

• 1 other identifier: IRB_00109729
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the main recipients of this procedure. In patients with persistent AF, or patients with paroxysmal AF and significant AF substrate other than the pulmonary veins, the utility of cryoballoon ablation is less straightforward. In such patients, the choices are to either use cryoballoon ablation in a PVI-only approach or alternatively, use cryoballoon ablation for PVI followed by the use of radiofrequency ablation for additional ablation and/or substrate modification. Substrate modification by targeting left atrial fibrosis detected on delayed enhancement magnetic resonance imaging (DE-MRI) is an increasingly popular approach with growing data showing its utility to decrease the risk of recurrence. The ability to use cryoballoon ablation for fibrosis based ablation in addition to PVI will therefore provide a significant advantage. This study will evaluate feasibility and the outcome of targeted ablation of left atrial fibrosis detected on DE-MRI in addition to pulmonary vein isolation using the Arctic Front Advance Cryoballoon Catheter.

Conditions

Atrial Fibrillation; Left Atrial Fibrosis

Keywords

Cryoballoon Ablation; Persistent atrial fibrillation; Paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence of Atrial Fibrillation

  Recurrence of atrial fibrillation will be defined by detection of an episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds during any of the study follow-up periods up to one year post-ablation.

  12 Months

Secondary Outcomes (1)

• Recurrence of Atrial Fibrillation Stratified by Atrial Fibrillation Type

  12 Months

Study Arms (1)

Cryoballoon Ablation

EXPERIMENTAL

Cryoballoon Ablation: PVI + substrate modification. Left atrial fibrosis ablation in addition to standard pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. Ablation will be performed utilizing the Medtronic Arctic Front Advance Cryoballoon catheter.

Device: Cryoballoon Ablation: PVI + substrate modification

Interventions

Cryoballoon Ablation: PVI + substrate modification DEVICE

Standard pulmonary vein isolation using cryoballoon ablation, followed by left atrial fibrosis substrate modification using cryoballoon ablation

Cryoballoon Ablation

Eligibility Criteria

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

You may qualify if:

• Referred for cryoballoon ablation of paroxysmal or persistent atrial fibrillation
• years of age or older
• Ability to give informed consent in accordance with University of Utah IRB guidelines

You may not qualify if:

• Previous ablation for atrial fibrillation or atypical atrial flutter
• Contraindication to MRI contrast agent
• Unquantifiable fibrosis or moderate to severe left-atrial fibrosis (≥ 20%)
• Contraindication for chronic anticoagulation therapy
• Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular disease within the last 2 months
• Implanted cardiac device
• Presence of left atrial thrombus
• Contraindications to cryoballoon ablation including history of cryoglobulinemia, active systemic infection, and presence of one or more pulmonary vein stents
• New York Heart Association (NYHA) class IV heart failure
• Women who are currently pregnant or breast feeding or using unreliable contraceptive measures if premenopausal
• Enrollment in another investigational trial
• Untreated hyperthyroidism or hypothyroidism
• Life expectancy \< 12 months due to a terminal disease
• Presence of phrenic nerve injury at baseline elicited by hemidiaphragmatic paralysis on pre-ablation chest x-ray

Sponsors & Collaborators

• University of Utah: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Nassir F Marrouche, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single-center, open-label pilot study

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share