N/A
N=64
RADAR Clinical Trial
Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03263702 ↗Enrolled (actual)
64
Serious AEs
23.4%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Atrial Fibrillation Termination — 23; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computational Mapping Algorithm (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Vivek Reddy
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Atrial Fibrillation Termination |
23; 12 | — |
| PRIMARY Number of Participants Free From Recurrent AT/AF on no AAD |
25; 13 | — |
| PRIMARY Number of Participants Free From Recurrent AT/AF With no or Some AAD |
25; 17 | — |
| SECONDARY Rate of Post-ablation Inducibility of AF |
61; 46 | — |
| SECONDARY Duration of RF Ablation |
323; 316 | — |
| SECONDARY Duration of Fluoro Time |
25.5; 24.1 | — |
| SECONDARY Duration of Exposure |
245; 241 | — |
| SECONDARY Duration of Procedure Time |
23.6; 34.5 | — |
| SECONDARY Number of Procedure-related Adverse Events |
7; 4 | — |
| SECONDARY Number of Major Adverse Cardiac Events (MACE) |
1; 1 | — |
| SECONDARY Number of Serious Adverse Events |
12; 8 | — |
Summary
This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age.
- Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
- Ability to understand the requirements of the study and sign the informed consent form.
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- Projected lifespan greater than 1 year.
Exclusion Criteria
- They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
- Rheumatic heart disease
- Current intra-cardiac thrombus
- History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
- Unstable angina
- CVA or TIA within 3 months
- Contraindication to anticoagulation
- Class IV HF
- Unable to sign consent
- Projected lifespan of < 1 year
- Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
- Participation in another study that would interfere with this study.
Data sourced from ClinicalTrials.gov (NCT03263702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.