Status:
TERMINATED
Model Based Fast Anatomical Mapping
Lead Sponsor:
Vivek Reddy
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
Detailed Description
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation. Specific...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Have AF as follows:
- Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting \< 7 days.
- Persistent AF - defined as AF that is sustained \> 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
- Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed)
- Have the ability to understand the requirements of the study and sign the informed consent form.
- Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements
Exclusion
- Rheumatic heart disease,
- Current intra-cardiac thrombus
- Class IV HF
- Unable to sign consent
- Unstable angina
- Recent cerebral ischemic events
- Contradiction to anticoagulation
- Prior cardiac surgery
- Complex congenital heart disease
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03349476
Start Date
April 16 2018
End Date
October 3 2022
Last Update
November 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029