Aortic Valve StenosisTELE-TAVINCT06602609
Remote Cardiovascular Monitoring in Post-TAVI Patients
A study testing Remote Patient Monitoring Strategy and Standard Medical Therapy in people with Aortic Valve Stenosis and Cardiac Conduction Disturbance, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health
- What is being tested?
- Remote Patient Monitoring Strategy and Standard Medical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 1 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age must be 18 years or above.
- 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.
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- 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.
Who cannot join
- Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital
London, W12 0NN
Adam Hartley, MBChB PhD
About this study
Official title: Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay.
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).
Read more
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.
Read the detailed description
Given the susceptibility of post-TAVI patients to bradyarrhythmias and extended hospitalisation is not economically plausible, a shift toward remote monitoring could be both justifiable and has the potential to enhance outcomes and able to predict deterioration following TAVI. Despite the well-characterized high safety and effectiveness profile of TAVI across various surgical risk groups, the adoption of same-day discharge remains limited. Addressing post-TAVI arrhythmias is crucial to minimising the total postprocedural length of stay. Therefore, by embracing a minimalist approach and leveraging the vastly grown operators experience, the current post-TAVI care could be further enhanced with the integration of remote monitoring. This strategic shift aligns with the objective of optimising care by the ability to predict deterioration that can be treated to avoid in-hospital care.
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:
- 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).
- 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
- Aortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health, Transcatheter Aortic Valve Implantation, TAVI
- Being tested
- Remote Patient Monitoring Strategy, Standard Medical Therapy
- Keywords
- POST-TAVI, Hospital Length of Stay, Same-Day Discharge, Remote Monitoring, Ambulatory ECG, Digital Health, Valvular Heart Disease, TAVI, TAVR, Medical Device, Hospital at Home, Home Health, Telemedicine, Virtual Health, ECG, EKG, RCT, Digital Innovation, Technology, Ambulatory
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient Monitoring StrategyOther
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 TherapyOther
Also called Current standard of care
No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group adheres to the best standard of care as per current practice. Receives: Other: Standard Medical Therapy |
| Remote Monitoring Group | Active comparator | 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. Receives: Other: Remote Patient Monitoring Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative length of stay within 30 days of the procedure.
Post-procedural hospital length of stay will be compared between study groups
Measured: 30 days
Secondary outcomes (6)
The difference in rate of new PPM implantation at 3 months.
Difference between intervention to control groups
Measured: 3 months
Rate of emergency room visits not requiring admission
Accident and Emergency (A\&E) visits, advised by research team and unadvised
Measured: 3 months
Number of all hospital admissions at 3 months
Planned admissions instigated by the research team vs. unplanned
Measured: 3 months
Mortality Rate at 30 days
Mortality rate will be compared in both study groups
Measured: 30 days
Patient score for the patient-reported anxiety improvement analysis
Patients in both study groups will fill out the questionnaire SHAI (Short Health Anxiety Inventory) score range 3 to 38 where 38 means lower anxiety.
Measured: at discharge and 30 days
Number of instances of major adverse cardiovascular events
Major adverse cardiovascular events in this study were recognised as myocardial infarction, cerebral vascular accident (CVA), and cardiovascular-related death.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, prospective, randomised controlled, parallel-group study with open-label randomisation concealment. A total of 216 patients will have a random assignment 1:1 into the active arm (remote monitoring) or control group (standard of care), employing computer-generated randomisation via a minimisation design based on sex and age (75 years ± 8 years).
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University
- Responsible party
- Sponsor
- Investigators
- Ramzi Khamis, MBChB DIC PhD FESC FRCP, Principal investigator, Imperial College London, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602609
- Sponsor's protocol ID
- 24HH8773
- Acronym
- TELE-TAVI
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study is complete and analysed, whilst individual patient results will not be disclosed, the overall research findings may be submitted for publication in a scientific journal and presented at scientific conferences following the completion of the study. A summary of the research findings will be uploaded onto the Imperial College London website. All data will be anonymised and kept confidential.
Publications
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.
PubMed 33332150Massoullie 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.
PubMed 27797979Natarajan 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.
PubMed 35699482Xu 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.
PubMed 35837611Glikson 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.
PubMed 34455430Prihadi 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.
PubMed 29037444Muntane-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.
PubMed 33083813Hartrampf 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.
PubMed 34934073Hanna 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.
PubMed 36562010Barker 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.
PubMed 35331450Rosseel 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.
PubMed 37645516Krishnaswamy 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.
PubMed 35331449Goel 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.
PubMed 35644697Panagides 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.
PubMed 34227916Iung 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.
PubMed 31510787