Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Eliminate Human AF (RECONFIRM)
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|ClinicalTrials.gov Identifier: NCT02456233|
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Conventional AF Ablation with PVI Procedure: FIRM-guided ablation plus PVI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Conventional AF Ablation with PVI
These patients will be treated by conventional AF ablation by pulmonary vein isolation (PVI) alone.
Procedure: Conventional AF Ablation with PVI
Trigger Based Ablation for AF, using Pulmonary Vein Isolation (PVI) alone
Experimental: FIRM-guided ablation plus PVI
These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM). Conventional ablation (PVI) will then be performed as part of the standard of care procedure.
Procedure: FIRM-guided ablation plus PVI
Substrate ablation for AF, via ablation of rotors and focal sources. Conventional (PVI) ablation will also be performed.
- Long term success [ Time Frame: 12 months ]Freedom from atrial fibrillation (AF) recurrence during the 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period.
- Long-term freedom from AF/AT [ Time Frame: 12 months ]Freedom from AF and atrial tachycardia (AT) during the 12 months after the initial AF ablation procedure, after an initial 3 month blanking (healing and stabilization) period. Atrial tachycardias (AT) include those arising from atrial regions where ablation was performed (such as left atrial tachycardia) as well as from regions where ablation was not performed (such as typical cavotricuspid isthmus dependent atrial flutter).
- Total ablation time [ Time Frame: 1 day ]Total ablation time will be recorded in all patients, measured as the cumulative application of energy from the first ablation lesion to the last lesion. These values will be compared between the FIRM-guided and conventional ablation groups. If ablation for AT/atrial flutter is pursued, this ablation time will be documented separately.
- Quality of Life [ Time Frame: 12 months ]Quantitative EuroQol EQ5D scores post-ablation will be compared to those pre-ablation at all time points separately and together (ANOVA)
- Adverse Events [ Time Frame: 12 months ]Adverse events will be adjudicated by an independent Data and Safety Monitoring Committee, who will determine whether they are or are not related to the procedure. The number and type of adverse events will be compared between FIRM-guided and conventional ablation groups.
- Healthcare Utilization [ Time Frame: 12 months ]Hospitalization, other procedures and healthcare utilization, adjudicated by an independent Data and Safety Monitoring Committee, will be compared between limbs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456233
|Contact: Sanjiv Narayan, MD, PhD||(650) firstname.lastname@example.org|
|Contact: Kathleen Mills, BA||(650) email@example.com|
|United States, California|
|Veterans Affairs Medical Center||Not yet recruiting|
|San Diego, California, United States, 92161|
|Contact: David E Krummen, MD firstname.lastname@example.org|
|Principal Investigator: David E Krummen, MD|
|Stanford, California, United States, 94305|
|Contact: Gerri O'Riordan, RN 650-725-5597 GORiordan@stanfordhealthcare.org|
|Principal Investigator:||Sanjiv Narayan, MD, PhD||Stanford University|