Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)

A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)

The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:

NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)

The above record was combined into one as both protocols are essentially identical (one is post market \[EU\] and the other pre-market \[Canada\] and one study report will be written that encompasses the data/results for both protocols.

• AcQMap System (Device): 3D imaging and mapping system for cardiac chambers

Primary outcomes

• Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) [24 hours]: MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.

Secondary outcomes

• Number of Participants Who Experienced at Least One Adverse Events. [12 Months]: Recording of all adverse events through 12 month follow-up
• Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. [24 hours]: Conversion to sinus rhythm post ablation
• Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. [6, 9, and 12 Months]: Freedom from AF

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Scheduled for an ablation of persistent atrial fibrillation

Exclusion Criteria:

* Any duration of continuous AF lasting longer than 12 months
* Previous AF ablation
* Significant structural heart disease
* Previous cerebral infarct
* Major bleeding disorders
* Pregnant or lactating

Participant flow

Outcome results

• Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) (Primary), Count of participants, Participants: AcQMap System 3
• Number of Participants Who Experienced at Least One Adverse Events. (Secondary), Number, participants: AcQMap System 1
• Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. (Secondary), Count of participants, Participants: AcQMap System 125
• Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. (Secondary), Count of participants, Participants: 6 Month Off AADs 79; 6 Month on AADs 49; 9 Months Off AADs 65; 9 Months on AADs 36; 12 Months Off AADs 84; 12 Months on AADs 52

Adverse events

Time frame: Adverse Events were collected through 12 months post-procedure.

Serious adverse events by term

Other adverse events by term

6 more terms not shown.

Limitations and caveats: Identified limitations * Not an RCT limiting the comparability of the results to current SOC * A first-generation device study with limited experienced users. Outcome measures may not be reflective of current clinical results.

• Results publication: Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27. PMID 31242746

• Study Protocol and Statistical Analysis Plan (PDF, 2019-05-20)

• Stephan Willems, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf (UKE)