Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 5:20 PM
Study NCT ID:
NCT02456233
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2015-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Eliminate Human AF
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Randomized Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Eliminate Human Atrial Fibrillation (RECONFIRM): A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECONFIRM
Brief Summary:
This prospective randomized study will assess the safety and efficacy of FIRM-guided ablation (FIRM+PVI) compared to pulmonary vein isolation (PVI) without FIRM, for the treatment of symptomatic atrial fibrillation.
Detailed Description:
Atrial fibrillation (AF) affects over 2 millions Americans. AF may reduce cardiac performance and may result in thrombus formation in the left atrium and thromboembolic events, such as stroke. Ablation to eliminate the causes of this arrhythmia is increasingly performed since pharmacological therapy is suboptimal. Ablation currently targets triggers, by ablating left atrial areas outside the pulmonary veins (pulmonary vein isolation, PVI) in subjects with symptomatic AF who have failed drugs. Unfortunately, this has mixed success with the best outcomes being 50-70% freedom from AF at 1 year post ablation.
A major issue with AF therapy is the lack of knowledge about critical regions of the heart that cause and sustain AF. A recent trial (STAR-AF2) showed that ablating regions empirically - i.e. without defining their role in AF(lines or fractionated electrograms) - did not improve patient outcomes compared to PVI alone (Verma et al, NEJM 2015). However, this leaves us with PVI that had a 50% success rate in that trial and in several other trials even for paroxysmal AF.
We hypothesize that guiding ablation to critical arrhythmia-targeting zones will improve success over PVI alone. Specifically, we hypothesize that computational mapping of AF will find small regions called rotors and focal sources and ablate them, called Focal Impulse and Rotor Modulation (FIRM) ablation, shows promise at eliminating AF substrates. In many single center trials, FIRM improves results from PVI alone. This will be among the first randomized comparisons of FIRM ablation compared to PVI alone, and addresses an important question in the field.
A major issue with AF therapy is the lack of knowledge about critical regions of the heart that cause and sustain AF. A recent trial (STAR-AF2) showed that ablating regions empirically - i.e. without defining their role in AF(lines or fractionated electrograms) - did not improve patient outcomes compared to PVI alone (Verma et al, NEJM 2015). However, this leaves us with PVI that had a 50% success rate in that trial and in several other trials even for paroxysmal AF.
We hypothesize that guiding ablation to critical arrhythmia-targeting zones will improve success over PVI alone. Specifically, we hypothesize that computational mapping of AF will find small regions called rotors and focal sources and ablate them, called Focal Impulse and Rotor Modulation (FIRM) ablation, shows promise at eliminating AF substrates. In many single center trials, FIRM improves results from PVI alone. This will be among the first randomized comparisons of FIRM ablation compared to PVI alone, and addresses an important question in the field.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K24HL103800 | NIH | None | https://reporter.nih.gov/quic… | View |