RECRUITING

Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

Conditions

Atrial Fibrillation - Symptomatic Persistent atrial fibrillation Medication refractory atrial fibrillation Pulmonary vein isolation procedure Low voltage directed ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2. an approach of pulmonary vein isolation (PVI) alone.

Official Title

Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.

Quick Facts

Study Start:2019-07-14

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03355456

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Non-Paroxysmal Atrial Fibrillation. 2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD). 3. 18-85 year of age at time of consent. 4. Scheduled to undergo a clinically indicated AF ablation procedure. 5. Able and willing to comply with all protocol visit requirements. 6. Signed Patient Informed Consent (ICF). 7. Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure	1. History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE. * Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included. 2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure. 3. Ejection Fraction \< 0.20. 4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months. 5. Left atrial size \> 60 mm diameter on echocardiogram. 6. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment. 7. Severe pulmonary hypertension (PAP \> 70 mmHg) 8. Unstable valvular disease. 9. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause. 10. Poor candidate for general anesthesia. 11. Anticipated survival \< 1 year. 12. MI or CABG within 3 months. 13. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure. 14. Any documented thromboembolic event within 6 months of the ablation procedure. 15. Contraindication to anticoagulation. 16. Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks. 17. Significant congenital anomaly or medical condition that may affect the integrity of study data. 18. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile. 19. Active enrollment in another investigational study involving a drug or device. 20. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol. 21. Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.

Inclusion Criteria

Exclusion Criteria

1. Non-Paroxysmal Atrial Fibrillation.
2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
3. 18-85 year of age at time of consent.
4. Scheduled to undergo a clinically indicated AF ablation procedure.
5. Able and willing to comply with all protocol visit requirements.
6. Signed Patient Informed Consent (ICF).
7. Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure

1. History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
* Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
3. Ejection Fraction \< 0.20.
4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
5. Left atrial size \> 60 mm diameter on echocardiogram.
6. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
7. Severe pulmonary hypertension (PAP \> 70 mmHg)
8. Unstable valvular disease.
9. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
10. Poor candidate for general anesthesia.
11. Anticipated survival \< 1 year.
12. MI or CABG within 3 months.
13. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
14. Any documented thromboembolic event within 6 months of the ablation procedure.
15. Contraindication to anticoagulation.
16. Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks.
17. Significant congenital anomaly or medical condition that may affect the integrity of study data.
18. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
19. Active enrollment in another investigational study involving a drug or device.
20. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.
21. Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.

Contacts and Locations

Study Contact

Peter Leo BS, RN

CONTACT

216-778-2714

pleo@metrohealth.org

Principal Investigator

Ohad Ziv, MD

PRINCIPAL_INVESTIGATOR

The MetroHealth System

Study Locations (Sites)

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Collaborators and Investigators

Sponsor: Ohad Ziv

Ohad Ziv, MD, PRINCIPAL_INVESTIGATOR, The MetroHealth System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-14

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2019-07-14

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Persistent atrial fibrillation
Medication refractory atrial fibrillation
Pulmonary vein isolation procedure
Low voltage directed ablation

Additional Relevant MeSH Terms

Atrial Fibrillation - Symptomatic