Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
216 participants
INTERVENTIONAL
2024-09-11
2028-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care).
Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management.
Participants in the control group will: adhere to the best standard of care as per current practice.
Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
NCT06596460
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
NCT03303612
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
NCT05261204
Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement
NCT03173079
Outcome Prediction in Patients With Aortic Stenosis After TAVI
NCT06043180
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Technology-enabled patient care and monitoring has been steadily improving, and AI-enabled remote patient monitoring devices has brought a crucial advantage to an outside-of-hospital cardiac investigation. The potential to remotely detect any adverse effects that patients might develop after the procedure is promising. There is an increased uptake of ECG telemetry, which might serve as a valuable tool that may significantly reduce hospital LOS at 30 days and possibly could reduce 3 months' adverse outcomes. This approach may enhance patient care and optimise post-TAVI outcomes through an efficient patient-tailored approach. Several studies have utilised remote or ambulatory ECG for post-TAVI on different clinical outcomes - however, to date, no RCT has been conducted using this approach. The findings of remote ECG monitoring studies are inconsistent with various monitoring periods and patient selection criteria. Although such studies utilised ECG monitoring, they did not integrate a strategy or pathway for out-of-hospital monitoring and clinical decision algorithms during home monitoring. To date, the TELE-TAVI trial will be the first monitoring study to incorporate live event detection and alert notification system supported by the bespoke Smartcardia 7-lead continuous ECG patch monitor in an RCT.
In order to better understand the impact of remote patient monitoring after TAVI, this trial proposes the utilisation of a remote monitoring algorithm to provide essential clinical data for guiding management, with the primary aim of reducing postprocedural hospital length of stay and readmissions. This strategic technology integration aims to address the gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care.
Thus, it has been hypothesised that:
1. A remote patient monitoring protocol-driven strategy for same-day discharge, post-TAVI, is superior to the current standard of care follow-up in reducing cumulative 30-day hospital length of stay (LOS).
2. The novel remote patient monitoring strategy, supported by a clinical decisions algorithm, is more effective at prioritising patient presentations and optimising outcomes through early identification of adverse events, such as the need for a pacemaker, when compared to the standard of care.
The principal aims of this clinical randomised trial are:
* To facilitate a safe same-day discharge after TAVI through a remote monitoring approach in order to reduce postprocedural hospitalisation.
* To integrate an algorithm-based clinical decision-making protocol that enhances remote monitoring and the detection of post-TAVI adverse events, particularly focusing on cardiac conduction complications.
* To test the effectiveness of the remote monitoring strategy in the cost-effectiveness of post-TAVI patients' hospital admission and re-admission.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
The control group adheres to the best standard of care as per current practice.
Standard Medical Therapy
No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information
Remote Monitoring Group
Those in the remote monitoring group will be given four devices, which will help the research team make decisions about their health condition based on the data collected. The active arm group will wear the continuous ECG device for 72 hours from discharge and will be instructed to acquire a daily 12-lead ECG and record vital signs until day 7 of hospital discharge. Additionally, participants will utilise 12-lead ECG and vital signs will be measured only when experiencing symptoms.
Remote Patient Monitoring Strategy
Continuous remote monitoring with the SmartCardia device includes continuous heart rate and cardiac conduction rhythm tracking through a 7-lead ECG enhanced by machine learning. This system can detect cardiac rhythm disturbances, measure breathing and heart rate, and provide live-alert notifications. Daily 12-lead ECG will be collected from each patient for 7 days after discharge; patients are instructed to perform a daily 12-lead ECG on the SHL device, along with recording blood pressure and oxygen saturation levels. Each ECG is interpreted by the trial team, and a cardiologist\'s interpretation is confirmed, and patients will undergo remote consultations with a cardiologist or research nurse each day if needed. During the initial 30 days of patient recruitment, if the individual exhibits potential cardiac symptoms, they can activate a remote consultation by performing an extra 12-lead ECG and recording blood pressure and oxygen saturation levels.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remote Patient Monitoring Strategy
Continuous remote monitoring with the SmartCardia device includes continuous heart rate and cardiac conduction rhythm tracking through a 7-lead ECG enhanced by machine learning. This system can detect cardiac rhythm disturbances, measure breathing and heart rate, and provide live-alert notifications. Daily 12-lead ECG will be collected from each patient for 7 days after discharge; patients are instructed to perform a daily 12-lead ECG on the SHL device, along with recording blood pressure and oxygen saturation levels. Each ECG is interpreted by the trial team, and a cardiologist\'s interpretation is confirmed, and patients will undergo remote consultations with a cardiologist or research nurse each day if needed. During the initial 30 days of patient recruitment, if the individual exhibits potential cardiac symptoms, they can activate a remote consultation by performing an extra 12-lead ECG and recording blood pressure and oxygen saturation levels.
Standard Medical Therapy
No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care:
* Vascular: Controlled with adequate vascular hemostasis.
* Neurological: Conscious and oriented, not under the effect of residual sedation.
* Cardiac: No significant pericardial effusion.
* Elective non-emergent patient admission and nonelective cases fitting discharge criteria.
* Comfortable ambulation post-procedure.
* The patient or their caregiver must have access to a smart device.
* Ability to provide informed consent (the patient must be alert and oriented for consent).
* Adequate social support.
Exclusion Criteria
* Patients with a permanent (pre-existing or new) implanted pacing device.
* Procedural failure in device delivery.
* Major vascular access complications require patients to stay.
* Inability to engage with the technology.
* Significant communication barrier.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Imperial College London
OTHER
King Khalid University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ramzi Khamis, MBChB DIC PhD FESC FRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College London, Imperial College Healthcare NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hammersmith Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
Massoullie G, Bordachar P, Irles D, Caussin C, Da Costa A, Defaye P, Jean F, Mechulan A, Mondoly P, Souteyrand G, Pereira B, Ploux S, Eschalier R. Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study. BMJ Open. 2016 Oct 26;6(10):e010485. doi: 10.1136/bmjopen-2015-010485.
Natarajan MK, Sheth TN, Wijeysundera HC, Chavarria J, Rodes-Cabau J, Velianou JL, Radhakrishnan S, Newman T, Smith A, Wong JA, Schwalm JD, Duong M, Mian RI, Bishop MG, Healey JS. Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study. Europace. 2022 Oct 13;24(9):1475-1483. doi: 10.1093/europace/euac042.
Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022.
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
Prihadi EA, Leung M, Vollema EM, Ng ACT, Ajmone Marsan N, Bax JJ, Delgado V. Prevalence and Prognostic Relevance of Ventricular Conduction Disturbances in Patients With Aortic Stenosis. Am J Cardiol. 2017 Dec 15;120(12):2226-2232. doi: 10.1016/j.amjcard.2017.08.046. Epub 2017 Sep 18.
Muntane-Carol G, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre Hernandez JM, Asmarats L, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Arrhythmic burden in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement: 2-year results of the MARE study. Europace. 2021 Feb 5;23(2):254-263. doi: 10.1093/europace/euaa213.
Hartrampf B, Jochheim D, Steffen J, Czermak T, Sadoni S, Lemmermohle E, Klier I, Estner HL, Massberg S, Mehilli J, Lackermair K, Fichtner S. Permanent pacemaker dependency in patients with new left bundle branch block and new first degree atrioventricular block after transcatheter aortic valve implantation. Sci Rep. 2021 Dec 21;11(1):24383. doi: 10.1038/s41598-021-03667-0.
Hanna G, Macdonald D, Bittira B, Horlick E, Ali N, Atoui R, Alqahtani A, Fam N, Shurrab M, Spadafore J, Allen J, Cheema A, Nalla B, Pulkkinen C, Cote S, Hennessey H, Stringer M, Leblanc S, Collin J, Fenton J, Rheault-Henry M, Lauck S, Sathananthan J, Wood D, Alnasser S. The Safety of Early Discharge Following Transcatheter Aortic Valve Implantation Among Patients in Northern Ontario and Rural Areas Utilizing the Vancouver 3M TAVI Study Clinical Pathway. CJC Open. 2022 Aug 13;4(12):1053-1059. doi: 10.1016/j.cjco.2022.08.005. eCollection 2022 Dec.
Barker M, Sathananthan J, Perdoncin E, Devireddy C, Keegan P, Grubb K, Pop AM, Depta JP, Rai D, Abtahian F, Spence MS, Mailey J, Muir DF, Russo MJ, Pineda-Salazar J, Okoh A, Smith M, Dahle TG, Rana M, Alfadhel M, Meier D, Chatfield A, Akodad M, Chuang A, Samuel R, Nestelberger T, McAlister C, Lauck S, Webb JG, Wood DA. Same-Day Discharge Post-Transcatheter Aortic Valve Replacement During the COVID-19 Pandemic: The Multicenter PROTECT TAVR Study. JACC Cardiovasc Interv. 2022 Mar 28;15(6):590-598. doi: 10.1016/j.jcin.2021.12.046.
Rosseel L, Mylotte D, Cosyns B, Vanhaverbeke M, Zweiker D, Teles RC, Angeras O, Neylon A, Rudolph TK, Wykrzykowska JJ, Patterson T, Costa G, Ojeda S, Tzikas A, Abras M, Leroux L, Van Belle E, Tchetche D, Bleiziffer S, Swaans MJ, Parma R, Blackman DJ, Van Mieghem NM, Grygier M, Redwood S, Prendergast B, Van Camp G, De Backer O. Contemporary European practice in transcatheter aortic valve implantation: results from the 2022 European TAVI Pathway Registry. Front Cardiovasc Med. 2023 Aug 14;10:1227217. doi: 10.3389/fcvm.2023.1227217. eCollection 2023.
Krishnaswamy A, Isogai T, Agrawal A, Shekhar S, Puri R, Reed GW, Yun JJ, Unai S, Burns DJP, Vargo PR, Kapadia SR. Feasibility and Safety of Same-Day Discharge Following Transfemoral Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2022 Mar 28;15(6):575-589. doi: 10.1016/j.jcin.2022.01.013.
Goel A, Malik AH, Bandyopadhyay D, Chakraborty S, Gupta R, Abbott JD, Ahmad H. The 30-Day Readmission Rate of Same-Day Discharge Following Transcatheter Aortic Valve Implantation (from National Readmission Database 2015 to 2019). Am J Cardiol. 2022 Aug 1;176:112-117. doi: 10.1016/j.amjcard.2022.04.033. Epub 2022 May 27.
Panagides V, Alperi A, Mesnier J, Philippon F, Bernier M, Rodes-Cabau J. Heart failure following transcatheter aortic valve replacement. Expert Rev Cardiovasc Ther. 2021 Aug;19(8):695-709. doi: 10.1080/14779072.2021.1949987. Epub 2021 Jul 6.
Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.
Nazzari H, Hawkins NM, Ezekowitz J, Lauck S, Ding L, Polderman J, Yu M, Boone RH, Cheung A, Ye J, Wood D, Webb J, Toma M. The Relationship Between Heart-Failure Hospitalization and Mortality in Patients Receiving Transcatheter Aortic Valve Replacement. Can J Cardiol. 2019 Apr;35(4):413-421. doi: 10.1016/j.cjca.2018.11.016. Epub 2018 Nov 28.
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.
VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
Taylor CJ, Ordonez-Mena JM, Jones NR, Roalfe AK, Myerson SG, Prendergast BD, Hobbs FR. Survival of people with valvular heart disease in a large, English community-based cohort study. Heart. 2021 Aug;107(16):1336-1343. doi: 10.1136/heartjnl-2020-318823. Epub 2021 May 24.
Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
Patel KP, Lim WY, Pavithran A, Assadi R, Wan D, Kennon S, Ozkor M, Earley M, Sporton S, Dhinoja M, Hayward C, Muthumala A, Hunter R, Lowe M, Lambiase P, Segal O, Mathur A, Schilling R, Baumbach A, Mullen MJ, Chow AW. Early pacemaker implantation for transcatheter aortic valve implantation is safe and effective. Pacing Clin Electrophysiol. 2022 Jan;45(1):103-110. doi: 10.1111/pace.14397. Epub 2021 Dec 26.
d'Arcy JL, Coffey S, Loudon MA, Kennedy A, Pearson-Stuttard J, Birks J, Frangou E, Farmer AJ, Mant D, Wilson J, Myerson SG, Prendergast BD. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J. 2016 Dec 14;37(47):3515-3522. doi: 10.1093/eurheartj/ehw229. Epub 2016 Jun 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24HH8773
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.