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| Name | Class |
|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | OTHER |
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To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.
Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.
Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
Primary Endpoint:
- First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.
Other events of interest:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOTRONIK ICDs with DX Technology | Device | The BIOTRONIK DX system offers a single chamber ICD that enables sensing of atrial signals through floating atrial dipoles, using a single ventricular lead. This technology enables enhanced arrhythmia diagnosis based on atrial and ventricular electrograms and, in addition, early diagnosis and automatic transmission of AF and heart failure (HF) diagnostic data. The DX technology provides several features in a single chamber device that are usually only found in dual chamber devices, including atrial diagnostics and SVT discrimination - early detection of SAF, increased diagnostics accuracy, dual-chamber discrimination. Nevertheless, the benefits of a single chamber device are preserved: reduced lead complications, reduced procedure complexity, elimination of costs for atrial lead. The DX system also integrates with BIOTRONIK Home Monitoring, allowing physicians to remotely follow their patients' clinical and device statuses with daily updates. |
| Measure | Description | Time Frame |
|---|---|---|
| New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes | All patients enrolled presented with sinus rhythm, confirmed also during the implant. Outcome was considered positive with the occurence of first confirmed episode of Atrial Fibrillation (AF) or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to BIOTRONIK's Home Monitoring Service Center (HMSC), lasting at least 30 seconds to be considered relevant. The adjudication was carried out by the independent investigator in charge of the remote monitoring. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform | All patients enrolled received a remote monitoring unit (BIOTRONIK's CARDIOMESSENGER SMART) providing automatic telemetry (read only) for data gathering and encrypted transmission to BIOTRONIK's Home Monitoring Service Center (HMSC). This outcome represents the percentage of days with successful Home Monitoring transmissions after the first recorded transmission. The Home Monitoring system automatically sends encrypted data through the mobile network to the BIOTRONIK Home Monitoring Service Center (HMSC), using cellular telephone network for data transmission. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Primary Endpoint at 90 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed. | 90 days |
| Cumulative Incidence of First AF/AFL/SVT Episode at 90 Days |
Inclusion Criteria:
Exclusion Criteria:
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Patients requiring an ICD implant
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| Name | Affiliation | Role |
|---|---|---|
| Carlos CK Kalil, M.D., Ph.D. | Santa Casa de Misericórdia de Porto Alegre - Brugada Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericórdia de Porto Alegre - Brugada Institute | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22236222 | Background | Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575. | |
| 12668495 | Background |
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Number of Participants Started: 50 Number of Participants Excluded Before Assignment: 0 Reason for Exclusion: Not applicable - all enrolled patients were assigned and implanted.
Recruitment Status: Completed Enrollment Start Date: November 24, 2021 Enrollment End Date (original): December 12, 2023 Enrollment End Date (actual): December 31, 2024 Study Completion Date (original): July 31, 2024 Study Completion Date (actual): July 31, 2025 Why Study Stopped Early: Enrollment stopped after 50 patients due to decreasing recruitment rate and sufficient data for primary endpoint analysis. Timeline extended due to Covid-19 crisis.
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: SAFE-DX-HOME Group | Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: SAFE-DX-HOME Group | Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | New Onset of Atrial Fibrillation, Atrial Flutter or Supraventricular Tachycardia Recorded Episodes | All patients enrolled presented with sinus rhythm, confirmed also during the implant. Outcome was considered positive with the occurence of first confirmed episode of Atrial Fibrillation (AF) or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to BIOTRONIK's Home Monitoring Service Center (HMSC), lasting at least 30 seconds to be considered relevant. The adjudication was carried out by the independent investigator in charge of the remote monitoring. | All 50 enrolled patients were included in the analysis population. No patients were excluded after enrollment. | Posted | Number | participants | 12 months |
|
12 months
Adverse events were collected throughout the 12-month follow-up period and categorized as serious or non-serious, and as related or unrelated to the investigational device or procedure. Events were reported by investigators using electronic case report forms and reviewed during monitoring visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: SAFE-DX-HOME Group | Patients with an indication for single-chamber ICD implantation were enrolled and implanted with a BIOTRONIK DX ICD system. All patients were followed for 12 months with remote monitoring via BIOTRONIK Home Monitoring. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular lead perforation | Surgical and medical procedures | Systematic Assessment | Required open-heart surgery; device-related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment | Detected by Home Monitoring; no intervention required. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. LUCIANO JANNUZZI CARNEIRO, Project Manager | BIOTRONIK Co.Med. LTDA (BRAZIL) | +55 11 99424-1915 | luciano.carneiro@biotronik.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Statistical analysis described inside the protocol | Aug 4, 2022 | Oct 2, 2025 | Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Statistical analysis described inside the protocol | Aug 4, 2022 | Mar 3, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 4, 2022 | Oct 2, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 months |
| Cardiologic Hospitalization | Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period. | 12 months |
| Device Related Complication | A composite outcome of any of the following device-related complications: Number of patients who need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death, or wound infection, within 60 days after the ICD insertion. | 60 days |
Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed. |
| 90 days |
| Cumulative Incidence of First AF/AFL/SVT Episode at 180 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 180 days. No hypothesis testing was performed. | 180 days |
| Cumulative Incidence of First AF/AFL/SVT Episode at 360 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 360 days. No hypothesis testing was performed. | 360 days |
| BIOTRONIK Coml Médica LTDA |
| São Paulo |
| 01533-000 |
| Brazil |
| Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24. |
| 23677314 | Background | Peterson PN, Varosy PD, Heidenreich PA, Wang Y, Dewland TA, Curtis JP, Go AS, Greenlee RT, Magid DJ, Normand SL, Masoudi FA. Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention. JAMA. 2013 May 15;309(19):2025-34. doi: 10.1001/jama.2013.4982. |
| 22529229 | Background | Matlock DD, Peterson PN, Wang Y, Curtis JP, Reynolds MR, Varosy PD, Masoudi FA. Variation in use of dual-chamber implantable cardioverter-defibrillators: results from the national cardiovascular data registry. Arch Intern Med. 2012 Apr 23;172(8):634-41; discussion 641. doi: 10.1001/archinternmed.2012.394. |
| 21867834 | Background | Dewland TA, Pellegrini CN, Wang Y, Marcus GM, Keung E, Varosy PD. Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry. J Am Coll Cardiol. 2011 Aug 30;58(10):1007-13. doi: 10.1016/j.jacc.2011.04.039. |
| 9741514 | Background | Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703. doi: 10.1016/s0735-1097(98)00297-6. |
| 20170816 | Background | Lee DS, Krahn AD, Healey JS, Birnie D, Crystal E, Dorian P, Simpson CS, Khaykin Y, Cameron D, Janmohamed A, Yee R, Austin PC, Chen Z, Hardy J, Tu JV; Investigators of the Ontario ICD Database. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010 Feb 23;55(8):774-82. doi: 10.1016/j.jacc.2009.11.029. |
| 16801463 | Background | Healey JS, Toff WD, Lamas GA, Andersen HR, Thorpe KE, Ellenbogen KA, Lee KL, Skene AM, Schron EB, Skehan JD, Goldman L, Roberts RS, Camm AJ, Yusuf S, Connolly SJ. Cardiovascular outcomes with atrial-based pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Circulation. 2006 Jul 4;114(1):11-7. doi: 10.1161/CIRCULATIONAHA.105.610303. Epub 2006 Jun 26. |
| 4434373 | Background | Castellanos A, Berkovits BV, Castillo CA, Befeler B. Sextapolar catheter electrode for temporary sequential atrioventricular pacing. Cardiovasc Res. 1974 Sep;8(5):712-4. doi: 10.1093/cvr/8.5.712. No abstract available. |
| 80685 | Background | Curry PV, Raper DA. Single lead for permanent physiological cardiac pacing. Lancet. 1978 Oct 7;2(8093):757-9. doi: 10.1016/s0140-6736(78)92647-8. |
| 15511240 | Background | Ovsyshcher IE, Crystal E. VDD pacing: under evaluated, undervalued, and underused. Pacing Clin Electrophysiol. 2004 Oct;27(10):1335-8. doi: 10.1111/j.1540-8159.2004.00635.x. No abstract available. |
| 25228132 | Background | Shurrab M, Elitzur Y, Healey JS, Gula L, Kaoutskaia A, Israel C, Lau C, Crystal E. VDD vs DDD pacemakers: a meta-analysis. Can J Cardiol. 2014 Nov;30(11):1385-91. doi: 10.1016/j.cjca.2014.04.035. Epub 2014 May 28. |
| 12164450 | Background | Gradaus R, Gonska BD, Stellbrink C, Cron T, Tebbenjohanns J, Blomstrom-Lundqvist C, Himmrich E, Salerno JA, Osswald S, Gommer ED, Van Veen BK, Bocker D. European clinical experience with a dual chamber single pass sensing and pacing defibrillation lead. Pacing Clin Electrophysiol. 2002 Jul;25(7):1079-86. doi: 10.1046/j.1460-9592.2002.01079.x. |
| 11341077 | Background | Gradaus R, Block M, Dorszewski A, Schriever C, Hammel D, Scheld HH, Borggrefe M, Breithardt G, Bocker D. Implantation of a dual chamber pacing and sensing single pass defibrillation lead. Pacing Clin Electrophysiol. 2001 Apr;24(4 Pt 1):416-23. doi: 10.1046/j.1460-9592.2001.00416.x. |
| 14516332 | Background | Niehaus M, de Sousa M, Klein G, Korte T, Pfeiffer D, Walles T, Raymondos K, Tebbenjohanns J. Chronic experiences with a single lead dual chamber implantable cardioverter defibrillator system. Pacing Clin Electrophysiol. 2003 Oct;26(10):1937-43. doi: 10.1046/j.1460-9592.2003.00299.x. |
| 23692262 | Background | Safak E, Schmitz D, Konorza T, Wende C, De Ros JO, Schirdewan A; Linox DX Study Investigators. Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole. Pacing Clin Electrophysiol. 2013 Aug;36(8):952-62. doi: 10.1111/pace.12171. Epub 2013 May 21. |
| 24809851 | Background | Iori M, Giacopelli D, Quartieri F, Bottoni N, Manari A. Implantable cardioverter defibrillator system with floating atrial sensing dipole: a single-center experience. Pacing Clin Electrophysiol. 2014 Oct;37(10):1265-73. doi: 10.1111/pace.12421. Epub 2014 May 9. |
| 12771010 | Background | Vermes E, Tardif JC, Bourassa MG, Racine N, Levesque S, White M, Guerra PG, Ducharme A. Enalapril decreases the incidence of atrial fibrillation in patients with left ventricular dysfunction: insight from the Studies Of Left Ventricular Dysfunction (SOLVD) trials. Circulation. 2003 Jun 17;107(23):2926-31. doi: 10.1161/01.CIR.0000072793.81076.D4. Epub 2003 May 27. |
| 25282033 | Background | Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1. |
| 19723701 | Background | Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1. |
| 25179766 | Background | Heidbuchel H, Hindricks G, Broadhurst P, Van Erven L, Fernandez-Lozano I, Rivero-Ayerza M, Malinowski K, Marek A, Romero Garrido RF, Loscher S, Beeton I, Garcia E, Cross S, Vijgen J, Koivisto UM, Peinado R, Smala A, Annemans L. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring. Eur Heart J. 2015 Jan 14;36(3):158-69. doi: 10.1093/eurheartj/ehu339. Epub 2014 Sep 1. |
| 24394157 | Result | DeCicco AE, Finkel JB, Greenspon AJ, Frisch DR. Clinical significance of atrial fibrillation detected by cardiac implantable electronic devices. Heart Rhythm. 2014 Apr;11(4):719-24. doi: 10.1016/j.hrthm.2014.01.001. Epub 2014 Jan 3. |
| 40176340 | Result | Mitacchione G, Curnis A, Celentano E, Rovaris G, Battista A, Marini M, Della Bella P, Santobuono VE, Biffi M, Tomasi L, Baroni M, Bontempi L, Nigro G, Di Lorenzo E, Ruggiero D, Franculli F, Pepi P, Viscusi M, Saporito D, Bertini M, Senatore G, Pedretti S, Pecora D, Forleo GB, Solimene F, Giordano V, Sacchi R, Giacopelli D, Gargaro A, Caravati F. New-Onset Device-Detected Atrial Fibrillation in Patients With Atrial Floating Dipole Implantable Cardioverter-Defibrillators: A Propensity Score-Matched Comparison With Conventional Dual-Chamber Systems. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1303-1313. doi: 10.1111/jce.16666. Epub 2025 Apr 2. |
| 37038759 | Result | Hindricks G, Theuns DA, Bar-Lev D, Anguera I, Ayala Paredes FA, Arnold M, Geller JC, Merkely B, Dyrda KM, Perings C, Maglia G, Ploux S, Meyhofer J, Blomstrom-Lundqvist C, Karjalainen P, Liang Y, Diemberger I, Wranicz JK, Barr C, Quartieri F, Timmel T, Bollmann A. Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole. Europace. 2023 May 19;25(5):euad061. doi: 10.1093/europace/euad061. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Successful Remote Monitoring Data Transmission to BIOTRONIK's HMSC Platform | All patients enrolled received a remote monitoring unit (BIOTRONIK's CARDIOMESSENGER SMART) providing automatic telemetry (read only) for data gathering and encrypted transmission to BIOTRONIK's Home Monitoring Service Center (HMSC). This outcome represents the percentage of days with successful Home Monitoring transmissions after the first recorded transmission. The Home Monitoring system automatically sends encrypted data through the mobile network to the BIOTRONIK Home Monitoring Service Center (HMSC), using cellular telephone network for data transmission. | All 50 enrolled patients were included in the analysis of Home Monitoring transmission performance. | Posted | Mean | Standard Deviation | percentage of days | 12 months |
|
|
|
| Secondary | Cardiologic Hospitalization | Number of patients with at least one hospitalization related to cardiologic outcomes during the follow-up period. | All 50 enrolled patients were included in the analysis of cardiologic hospitalizations. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Device Related Complication | A composite outcome of any of the following device-related complications: Number of patients who need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death, or wound infection, within 60 days after the ICD insertion. | All 50 enrolled patients were included in the analysis of device-related complications. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Other Pre-specified | Cumulative Incidence of Primary Endpoint at 90 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed. | Not Posted | 90 days | Participants |
| Other Pre-specified | Cumulative Incidence of First AF/AFL/SVT Episode at 90 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 90 days. No hypothesis testing was performed. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Other Pre-specified | Cumulative Incidence of First AF/AFL/SVT Episode at 180 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 180 days. No hypothesis testing was performed. | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Other Pre-specified | Cumulative Incidence of First AF/AFL/SVT Episode at 360 Days | Kaplan-Meier survival analysis was used to estimate the cumulative incidence of the first confirmed episode of AF, AFL, or SVT at 360 days. No hypothesis testing was performed. | Posted | Count of Participants | Participants | 360 days |
|
|
|
| 2 |
| 50 |
| 8 |
| 50 |
| 15 |
| 50 |
|
| Ventricular lead dislodgement | Surgical and medical procedures | Systematic Assessment | Required lead replacement; device-related. |
|
| Acute gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment | Led to cardiac arrest and death; unrelated to device. |
|
| Multi-organ failure (chagasic heart failure, hypothyroidism) | Cardiac disorders | Systematic Assessment | Multi-organ failure (chagasic heart failure, hypothyroidism) |
|
| Septic arthritis | Infections and infestations | Systematic Assessment | Hospitalized; unrelated. |
|
| Chest pain (coronary artery disease) | Cardiac disorders | Systematic Assessment | One required angioplasty; both unrelated. |
|
| Mental confusion/metabolic encephalopathy | Metabolism and nutrition disorders | Systematic Assessment | Hospitalized; unrelated. |
|
| Ventricular fibrillation (shock delivered) | Cardiac disorders | Systematic Assessment | Treated with shock; unrelated. |
|
| Fever of unknown origin | Infections and infestations | Systematic Assessment | Hospitalized; unrelated. |
|
| Paroxysmal atrial fibrillation | Cardiac disorders | Systematic Assessment | Pharmacological cardioversion; unrelated. |
|
| Stroke-like symptoms | Nervous system disorders | Systematic Assessment | Investigated for meningoencephalitis; unrelated. |
|
|
| Paroxysmal atrial fibrillation | Cardiac disorders | Systematic Assessment | Managed with medication or no intervention. |
|
| Ventricular fibrillation | Cardiac disorders | Systematic Assessment | Detected and treated by device; no complications. |
|
| Supraventricular Tachycardia (SVT) | Cardiac disorders | Systematic Assessment | Episodes lasted <3 minutes; asymptomatic or mild symptoms. |
|
Not provided
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