Remote Cardiovascular Monitoring in Post-TAVI Patients

NCT06602609 | Recruiting DMC

• 1 other identifier: 24HH8773
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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. 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). 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.

Conditions

TAVI; Aortic Valve Stenosis; Cardiac Conduction Disturbance; Digital Health; Transcatheter Aortic Valve Implantation

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; Cardiology; Post-Acute; Post Acute; Digital Technology; Electrocardiogram; Clinical Trials; Telehealth; Home Telemetry

Outcome Measures

Primary Outcomes (1)

• Cumulative length of stay within 30 days of the procedure.

  Post-procedural hospital length of stay will be compared between study groups

  30 days

Secondary Outcomes (6)

• The difference in rate of new PPM implantation at 3 months.

  3 months

• Rate of emergency room visits not requiring admission

  3 months

• Number of all hospital admissions at 3 months

  3 months

• Mortality Rate at 30 days

  30 days

• Patient score for the patient-reported anxiety improvement analysis

  at discharge and 30 days

Study Arms (2)

Control Group

OTHER

The control group adheres to the best standard of care as per current practice.

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.

Other: Remote Patient Monitoring Strategy

Interventions

Remote Patient Monitoring Strategy OTHER

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.

Remote Monitoring Group

Standard Medical Therapy OTHER

No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information

Also known as: Current standard of care

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• King Khalid University: collaborator

Study Sites (1)

Hammersmith Hospital

London, W12 0NN, United Kingdom

RECRUITING

Related Publications (24)

• 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.

  PMID: 33332150 BACKGROUND

• 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.

  PMID: 27797979 BACKGROUND

• 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.

  PMID: 35699482 BACKGROUND

• 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.

  PMID: 35837611 BACKGROUND

• 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.

  PMID: 34455430 BACKGROUND

• 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.

  PMID: 29037444 BACKGROUND

• 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.

  PMID: 33083813 BACKGROUND

• 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.

  PMID: 34934073 BACKGROUND

• 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.

  PMID: 36562010 BACKGROUND

• 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.

  PMID: 35331450 BACKGROUND

• 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.

  PMID: 37645516 BACKGROUND

• 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.

  PMID: 35331449 BACKGROUND

• 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.

  PMID: 35644697 BACKGROUND

• 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.

  PMID: 34227916 BACKGROUND

• 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.

  PMID: 31510787 BACKGROUND

• 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.

  PMID: 30853134 BACKGROUND

• 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.

  PMID: 30883053 BACKGROUND

• 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.

  PMID: 25788234 BACKGROUND

• 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.

  PMID: 33871579 BACKGROUND

• 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.

  PMID: 34453165 BACKGROUND

• 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.

  PMID: 34031157 BACKGROUND

• 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.

  PMID: 26541169 BACKGROUND

• 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.

  PMID: 34727374 BACKGROUND

• 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.

  PMID: 27354049 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ramzi Khamis, MBChB DIC PhD FESC FRCP

  Imperial College London, Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Badr Al Harbi, BScEMS, MSc

CONTACT

+44(0)7771429219; b.al-harbi23@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)