Single vs. Dual-DCCV in Obese Patients

Atrial Fibrillation Clinical Trial

Official title:

Efficacy and Safety of Dual Direct Current Cardioversion Versus Single Direct Current Cardioversion as an Initial Treatment Strategy in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539158
• Other study ID #: 2020.048
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: Ochsner Health System
• Contact: Nilmo Hernandez
• Phone: 504-703-3265
• Email: nilmo.hernandez[@]ochsner.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, the usual initial strategy for direct current cardioversion (DCCV) typically involves delivering 200J of electricity between two pads placed in the anterior and posterior positions (i.e., one on the chest and one on the back). However, this technique may be less likely to result in successful cardioversion in obese patients (BMI ≥30 kg/m2). Failure to achieve sinus rhythm then necessitates additional shocks, which still may ultimately fail to terminate the patient's atrial fibrillation, thereby increasing the likelihood of adverse events from multiple cardioversion attempts

"Dual-DCCV" is a technique in which four pads are used to deliver two simultaneous shocks of 200J, totaling 400J. Guidelines published by the American Heart Association/American College of Cardiology/Heart Rhythm Society and the European Society of Cardiology provide only general guidance regarding the appropriate technique and energy selection in patients undergoing cardioversion, with no specific recommendations pertaining to dual-DCCV or obese patients.

This study aims to assess the safety and efficacy of dual-DCCV as an initial treatment strategy, compared to standard single-DCCV, in the obese population.

Description:

Patients with sustained atrial fibrillation and obesity who are scheduled for a cardioversion for atrial fibrillation will provide written informed consent prior to starting the procedure. Patients will be randomly assigned in a 1:1 fashion to either single-DCCV or dual-DCCV treatment.

All patients will have 4 defibrillation pads placed: two pads placed in the right infraclavicular region and left flank region, plus two pads placed in the left infraclavicular and right flank region.

All patients will receive moderate sedation immediately prior to and during cardioversion.

Patients randomized to single-DCCV will be given a single 200J shock using the "primary" (or right anterior-left posterior) pair of pads. Patients assigned to dual-DCCV will receive two simultaneous 200J shocks (from both the "primary" and "secondary" set of defibrillator pads), totaling 400J delivered.

Patients in the single-DCCV group whose initial shock fails to restore normal sinus rhythm will be crossed over to the dual-DCCV group. Patients in the dual-DCCV group will receive up to three attempts at DCCV, as needed, at the discretion of the attending electrophysiologist.

One hour after cardioversion is completed, patients will be asked if they experienced any chest discomfort related to cardioversion and, if applicable, will rate their chest discomfort using a pain scale from 0-10.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• Atrial fibrillation (paroxysmal, persistent, and long-standing persistent)

• Obesity (defined as body mass index [BMI] =35 kg/m2). Of note, our current institutional protocol uses weight >250 lbs as an indication for dual-DCCV. An average height of 70 inches equates to BMI ~35 kg/m2

• Adequate anticoagulation at the time of the cardioversion (one of the following):

• Coumadin with an INR >2

• Direct oral anticoagulants (apixaban, dabigatran, rivaroxaban, or edoxaban)

• Subcutaneous low molecular-weight heparin or IV unfractionated heparin

• If the duration of atrial fibrillation is >48 hours (or unknown): trans-esophageal echocardiography (TEE) performed prior to cardioversion to document the absence of a left atrial thrombus, or continuous therapeutic anticoagulation for a minimum of 3 weeks prior to cardioversion

• Able to maintain uninterrupted therapeutic anticoagulation after cardioversion, for at least one month

Exclusion Criteria:

• Contraindication to cardioversion

• Not on adequate anticoagulation

• Emergent cardioversion

• Incarceration

• Pregnancy

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Direct Current Cardioversion
The patient is sedated and shocked using an external defibrillator to terminate the arrhythmia and restore a normal intrinsic rhythm (i.e., normal sinus rhythm).

Locations

Country	Name	City	State
United States	Ochsner Medical Center - West Bank	Gretna	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	LSU Health Sciences Center - Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Daniel P Morin, MD MPH FHRS

Country where clinical trial is conducted

United States, 

References & Publications (12)

Gallagher MM, Guo XH, Poloniecki JD, Guan Yap Y, Ward D, Camm AJ. Initial energy setting, outcome and efficiency in direct current cardioversion of atrial fibrillation and flutter. J Am Coll Cardiol. 2001 Nov 1;38(5):1498-504. doi: 10.1016/s0735-1097(01)01540-6. — View Citation

Gardner MW, Yadava M, Raitt MH, Elman MR, Zarraga IG, MacMurdy KS, Dalouk KA, Jessel PM. Effectiveness of dual external direct current cardioversion for initial cardioversion in atrial fibrillation. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1636-1643. doi: 10.1111/jce.13994. Epub 2019 Jun 11. — View Citation

Glover BM, Walsh SJ, McCann CJ, Moore MJ, Manoharan G, Dalzell GW, McAllister A, McClements B, McEneaney DJ, Trouton TG, Mathew TP, Adgey AA. Biphasic energy selection for transthoracic cardioversion of atrial fibrillation. The BEST AF Trial. Heart. 2008 Jul;94(7):884-7. doi: 10.1136/hrt.2007.120782. Epub 2007 Jun 25. — View Citation

Gurevitz OT, Ammash NM, Malouf JF, Chandrasekaran K, Rosales AG, Ballman KV, Hammill SC, White RD, Gersh BJ, Friedman PA. Comparative efficacy of monophasic and biphasic waveforms for transthoracic cardioversion of atrial fibrillation and atrial flutter. Am Heart J. 2005 Feb;149(2):316-21. doi: 10.1016/j.ahj.2004.07.007. — View Citation

January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7. — View Citation

Kirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U, Ravens U, Samol A, Steinbeck G, Treszl A, Wegscheider K, Breithardt G. Short-term versus long-term antiarrhythmic drug treatment after cardioversion of atrial fibrillation (Flec-SL): a prospective, randomised, open-label, blinded endpoint assessment trial. Lancet. 2012 Jul 21;380(9838):238-46. doi: 10.1016/S0140-6736(12)60570-4. Epub 2012 Jun 18. Erratum In: Lancet. 2012 Oct 13;380(9850):1308. — View Citation

Levy S, Lauribe P, Dolla E, Kou W, Kadish A, Calkins H, Pagannelli F, Moyal C, Bremondy M, Schork A, et al. A randomized comparison of external and internal cardioversion of chronic atrial fibrillation. Circulation. 1992 Nov;86(5):1415-20. doi: 10.1161/01.cir.86.5.1415. — View Citation

Mittal S, Ayati S, Stein KM, Schwartzman D, Cavlovich D, Tchou PJ, Markowitz SM, Slotwiner DJ, Scheiner MA, Lerman BB. Transthoracic cardioversion of atrial fibrillation: comparison of rectilinear biphasic versus damped sine wave monophasic shocks. Circulation. 2000 Mar 21;101(11):1282-7. doi: 10.1161/01.cir.101.11.1282. — View Citation

Oral H, Souza JJ, Michaud GF, Knight BP, Goyal R, Strickberger SA, Morady F. Facilitating transthoracic cardioversion of atrial fibrillation with ibutilide pretreatment. N Engl J Med. 1999 Jun 17;340(24):1849-54. doi: 10.1056/NEJM199906173402401. — View Citation

Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585. — View Citation

Shelton RJ, Brown BD, Allinson A, Johnson T, Smales C, Jolly S, Cleland JG. A comparison between monophasic and biphasic defibrillation for the cardioversion of persistent atrial fibrillation in patients with and without heart failure. Int J Cardiol. 2011 Mar 17;147(3):405-8. doi: 10.1016/j.ijcard.2009.09.545. Epub 2009 Oct 25. — View Citation

Voskoboinik A, Moskovitch J, Plunkett G, Bloom J, Wong G, Nalliah C, Prabhu S, Sugumar H, Paramasweran R, McLellan A, Ling LH, Goh CY, Noaman S, Fernando H, Wong M, Taylor AJ, Kalman JM, Kistler PM. Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial. J Cardiovasc Electrophysiol. 2019 Feb;30(2):155-161. doi: 10.1111/jce.13786. Epub 2018 Nov 14. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful return to sinus rhythm confirmed via rhythm strip ECG (regardless of duration) immediately following DCCV	Participant cardiac rhythm verified to have returned to sinus rhythm by single-lead rhythm strip ECG obtained via the defibrillator device.	0-1 hours